TriangleNCT05579782 · 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
The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level \<10 pg/mL.
The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.
Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure.
Reported safety
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-thyroid-cancer
- nct id
- NCT05579782
- 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-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0000
- source section id
- NCT05579782-om-0000
- source outcome index
- 0
- endpoint
- Subjects With Transient Hypoparathyroidism.
- endpoint definition
- The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level \<10 pg/mL.
- time origin
- 24-48 hours post-op
- 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-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0001
- source section id
- NCT05579782-om-0001
- source outcome index
- 1
- endpoint
- Patients With Hypoparathyroidism at Last Follow-up
- endpoint definition
- The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.
- time origin
- 2 days to 1 year after surgery
- 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-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0002
- source section id
- NCT05579782-om-0002
- source outcome index
- 2
- endpoint
- Overall Average Number of Parathyroid Glands Identified With High Confidence.
- endpoint definition
- Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
- time origin
- Immediate (during total thyroidectomy, up to 3 hours)
- 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-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0003
- source section id
- NCT05579782-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Frozen Sections Sent for Analysis.
- endpoint definition
- Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.
- time origin
- Immediate (during total thyroidectomy, up to 3 hours)
- 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-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0004
- source section id
- NCT05579782-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Auto-transplanted Parathyroid Glands
- endpoint definition
- Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
- time origin
- Immediate (during total thyroidectomy, up to 3 hours)
- 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-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0005
- source section id
- NCT05579782-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy
- endpoint definition
- Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure.
- time origin
- 0-72 hours after total thyroidectomy
- 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-thyroid-cancer
- nct id
- NCT05579782
- 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. Other Name: PTeye Device
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0000
- arm key
- OG001
- arm label
- NIRAF Detection Technology (-)
- regimen
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- 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. Other Name: PTeye Device
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0001
- arm key
- OG001
- arm label
- NIRAF Detection Technology (-)
- regimen
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- 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. Other Name: PTeye Device
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0002
- arm key
- OG001
- arm label
- NIRAF Detection Technology (-)
- regimen
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- 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. Other Name: PTeye Device
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0003
- arm key
- OG001
- arm label
- NIRAF Detection Technology (-)
- regimen
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- 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. Other Name: PTeye Device
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0004
- arm key
- OG001
- arm label
- NIRAF Detection Technology (-)
- regimen
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- 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. Other Name: PTeye Device
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- outcome key
- om-0005
- arm key
- OG001
- arm label
- NIRAF Detection Technology (-)
- regimen
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05579782-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-thyroid-cancer
- nct id
- NCT05579782
- harm key
- EG000
- source section id
- NCT05579782-ae
- event group key
- EG000
- event group label
- NIRAF Detection Technology (+)
- serious affected
- 0
- serious at risk
- 39
- other affected
- 0
- other at risk
- 39
- frequency threshold
- 0
- collection period
- 6 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-thyroid-cancer
- nct id
- NCT05579782
- harm key
- EG001
- source section id
- NCT05579782-ae
- event group key
- EG001
- event group label
- NIRAF Detection Technology (-)
- serious affected
- 0
- serious at risk
- 41
- other affected
- 0
- other at risk
- 41
- frequency threshold
- 0
- collection period
- 6 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