NCT04281875 · STUDY IN CONTEXT

Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient

Source null

→

secondary · POSTED

If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH \< 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.

Only participants with at least 6-months of follow-up were included in this analysis. The majority of follow-ups for thyroid surgery occured nat 5-14 days post-operation and most people do not return for longer follow-up unless they have on-going abnormal labs after that mark.

→

secondary · POSTED

Undetectable postoperative PTH and/or low calcium (total calcium \< 2mmol/L or 8 mg/dL, serum intact PTH \< 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy).

Not all of the patients come back for follow-up.

→

secondary · POSTED

Postoperative low calcium (total calcium \<8mg/dL or \<2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH \< 16 pg/mL or 1 pmol/L) within 24 hours after surgery

1 participant did not have their labs completed until 5-14 days post-operation.

→

secondary · POSTED

Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue

Source null

→

secondary · POSTED

Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-head-and-neck-neoplasm
nct id: NCT04281875
trial label: Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0000
source section id
NCT04281875-om-0000
source outcome index
0
endpoint
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
endpoint definition
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
time origin
Immediate. During total thyroidectomy procedure.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0001
source section id
NCT04281875-om-0001
source outcome index
1
endpoint
Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)
endpoint definition
If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH \< 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
time origin
6 months after total thyroidectomy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only participants with at least 6-months of follow-up were included in this analysis. The majority of follow-ups for thyroid surgery occured nat 5-14 days post-operation and most people do not return for longer follow-up unless they have on-going abnormal labs after that mark.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0002
source section id
NCT04281875-om-0002
source outcome index
2
endpoint
Postoperative Hypoparathyroidism/Hypocalcemia (Transient)
endpoint definition
Undetectable postoperative PTH and/or low calcium (total calcium \< 2mmol/L or 8 mg/dL, serum intact PTH \< 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy).
time origin
5 days to 6 months after total thyroidectomy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Not all of the patients come back for follow-up.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0003
source section id
NCT04281875-om-0003
source outcome index
3
endpoint
Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)
endpoint definition
Postoperative low calcium (total calcium \<8mg/dL or \<2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH \< 16 pg/mL or 1 pmol/L) within 24 hours after surgery
time origin
Within 24 hours after total thyroidectomy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
1 participant did not have their labs completed until 5-14 days post-operation.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0004
source section id
NCT04281875-om-0004
source outcome index
4
endpoint
Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).
endpoint definition
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
time origin
Immediate. During total thyroidectomy procedure.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0005
source section id
NCT04281875-om-0005
source outcome index
5
endpoint
Number of Auto-transplanted Parathyroid Glands
endpoint definition
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
time origin
Immediate. During total thyroidectomy procedure.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0000
arm key
OG000
arm label
NIRAF Detection Technology +
regimen
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0000
arm key
OG001
arm label
NIRAF Detection Technology -
regimen
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0001
arm key
OG000
arm label
NIRAF Detection Technology +
regimen
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0001
arm key
OG001
arm label
NIRAF Detection Technology -
regimen
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0002
arm key
OG000
arm label
NIRAF Detection Technology +
regimen
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
analyzed count
56
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0002
arm key
OG001
arm label
NIRAF Detection Technology -
regimen
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
analyzed count
50
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0003
arm key
OG000
arm label
NIRAF Detection Technology +
regimen
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0003
arm key
OG001
arm label
NIRAF Detection Technology -
regimen
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
analyzed count
79
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0004
arm key
OG000
arm label
NIRAF Detection Technology +
regimen
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0004
arm key
OG001
arm label
NIRAF Detection Technology -
regimen
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0005
arm key
OG000
arm label
NIRAF Detection Technology +
regimen
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
outcome key
om-0005
arm key
OG001
arm label
NIRAF Detection Technology -
regimen
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04281875-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
harm key
EG000
source section id
NCT04281875-ae
event group key
EG000
event group label
NIRAF Detection Technology +
serious affected
0
serious at risk
80
other affected
0
other at risk
80
frequency threshold
0
collection period
Adverse event data was collected for 2 years and 5 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-head-and-neck-neoplasm
nct id
NCT04281875
harm key
EG001
source section id
NCT04281875-ae
event group key
EG001
event group label
NIRAF Detection Technology -
serious affected
0
serious at risk
80
other affected
0
other at risk
80
frequency threshold
0
collection period
Adverse event data was collected for 2 years and 5 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice