NCT05152927 · REGISTRY CONDITION SEARCH

Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2025-12-15

The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis

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outcome · POSTED

Number of Participants With Persistent Hyperparathyroidism (Immediate)

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outcome · POSTED

Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)

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outcome · POSTED

Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)

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outcome · POSTED

Number of Parathyroid Glands (PG) Identified

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outcome · POSTED

Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)

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outcome · POSTED

Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands

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outcome · POSTED

Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent

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outcome · POSTED

Median Duration Taken to Identify First Parathyroid Gland

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outcome · POSTED

Median Duration Taken to Identify Last Parathyroid Gland

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outcome · POSTED

Median Duration of Parathyroidectomy (PTx) Procedure

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outcome · POSTED

Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize

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outcome · POSTED

Median Number of Nights in the Hospital After Parathyroidectomy

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outcome · POSTED

Median Number of 'False Positive' Tissue Samples Excised by Surgeon

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outcome · POSTED

Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions

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outcome · POSTED

Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * All adults \>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery * All adult (\>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: * Children and minors * Pregnant women * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy * Patients with secondary or tertiary hyperparathyroidism
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
For patients assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
intervention Names
Device: Parathyroid Eye (PTeye)
label
Parathyroid Eye (PTeye)
type
EXPERIMENTAL
description
The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
label
Usual Standard of Care
type
NO_INTERVENTION

interventions

arm Group Labels
Parathyroid Eye (PTeye)
description
Intraoperative Tool
name
Parathyroid Eye (PTeye)
other Names
Near Infrared Autofluorescence (NIRAF)
NIRAF detection modality
PTeye
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: SINGLE
masking Description: Only participants will be masked to the intervention
who Masked: PARTICIPANT

primary Purpose

PREVENTION

Enrollment

count: 79
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
measure
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
time Frame
At the end of the parathyroidectomy, up to 5 hours

secondary Outcomes

description
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
measure
Number of Participants With Persistent Hyperparathyroidism (Immediate)
time Frame
5-14 days after PTx procedure
description
Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
measure
Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)
time Frame
5-14 days after PTx procedure
description
If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
measure
Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)
time Frame
Up to 6 months after PTx procedure
description
Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
measure
Number of Parathyroid Glands (PG) Identified
time Frame
At the end of the parathyroidectomy, up to 5 hours
description
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
measure
Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)
time Frame
At the end of the parathyroidectomy, up to 5 hours
description
Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
measure
Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands
time Frame
At the end of the parathyroidectomy, up to 5 hours
description
The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab
measure
Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent
time Frame
At the end of the parathyroidectomy, up to 5 hours
description
Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
measure
Median Duration Taken to Identify First Parathyroid Gland
time Frame
During parathyroidectomy, up to 5 hours
description
Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
measure
Median Duration Taken to Identify Last Parathyroid Gland
time Frame
At the end of the parathyroidectomy, up to 5 hours
description
Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
measure
Median Duration of Parathyroidectomy (PTx) Procedure
time Frame
Up to 5 hours
description
Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L
measure
Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize
time Frame
At the end of the parathyroidectomy, up to 5 hours
description
Median number of nights spent in the hospital post-surgery is defined as having spent \<= 23 hours (0 nights) or \> 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.
measure
Median Number of Nights in the Hospital After Parathyroidectomy
time Frame
0-72 hours after PTx procedure

Full study description

brief Summary: The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
detailed Description: This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice. PRIMARY OBJECTIVES: I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues. II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries. III. Assess the impact of PTeye on minimizing risk of post-surgical complications. Participants will be randomized to either the experimental or control arm. The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not. For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. Participants will be follow-ed up for up to 6 months after surgery.

Source references

references

citation
McWade MA, Paras C, White LM, Phay JE, Mahadevan-Jansen A, Broome JT. A novel optical approach to intraoperative detection of parathyroid glands. Surgery. 2013 Dec;154(6):1371-7; discussion 1377. doi: 10.1016/j.surg.2013.06.046.
pmid
24238054
type
BACKGROUND
citation
Thomas G, Solorzano CC, Baregamian N, Mannoh EA, Gautam R, Irlmeier RT, Ye F, Nelson JA, Long SE, Gauger PG, Magner A, Metcalf T, Shirley LA, Phay JE, Mahadevan-Jansen A. Comparing intraoperative parathyroid identification based on surgeon experience versus near infrared autofluorescence detection - A surgeon-blinded multi-centric study. Am J Surg. 2021 Nov;222(5):944-951. doi: 10.1016/j.amjsurg.2021.05.001. Epub 2021 May 13.
pmid
34024629
type
BACKGROUND
citation
Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233.
pmid
40668552
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice