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

NCT05579782 | Completed Results DMC FDA Device

• 1 other identifier: 00040573
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Conditions

Postoperative Hypoparathyroidism; Thyroid Disease; Thyroid Neoplasms; Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

• Subjects With Transient Hypoparathyroidism.

  The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level \<10 pg/mL.

  24-48 hours post-op

• Patients With Hypoparathyroidism at Last Follow-up

  The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.

  2 days to 1 year after surgery

Secondary Outcomes (7)

• Overall Average Number of Parathyroid Glands Identified With High Confidence.

  Immediate (during total thyroidectomy, up to 3 hours)

• Number of Participants With Frozen Sections Sent for Analysis.

  Immediate (during total thyroidectomy, up to 3 hours)

• Number of Participants With Auto-transplanted Parathyroid Glands

  Immediate (during total thyroidectomy, up to 3 hours)

• Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy

  0-72 hours after total thyroidectomy

• Number of Participants With Inadvertently Resected Parathyroid Glands

  Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)

Study Arms (2)

NIRAF Detection Technology (+)

EXPERIMENTAL

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).

Device: NIRAF Detection Technology

NIRAF Detection Technology (-)

NO INTERVENTION

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).

Interventions

NIRAF Detection Technology DEVICE

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

NIRAF Detection Technology (+)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).
• (ii) All patients undergoing completion thyroidectomy.

You may not qualify if:

• (i) Patients with concurrent parathyroid disease.
• (ii) Patients with incidental enlarged parathyroid discovered during TTx.
• (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Cancer Institute (NCI): collaborator
• Vanderbilt University: collaborator

Study Sites (1)

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Thyroid Diseases; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Results Point of Contact

• Title: Tracy Wang, MD
• Organization: Medical College of Wisconsin

tswang@mcw.edu

414-955-1459

Study Officials

• Tracy S Wang, MD, MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants will be masked to the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND) in the interventional group. Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology). The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nanometer (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 Milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 5, 2022
• Primary Completion: May 29, 2024
• Study Completion: December 31, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)