Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

NCT05022667 | Completed Results FDA Device

• 1 other identifier: HUM00194322
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Conditions

Thyroid Neoplasms; Thyroid Diseases; Hypoparathyroidism; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases

Keywords

Total Thyroidectomy; Intraoperative Parathyroid Identification; Near Infrared Autofluorescence; Postoperative Hypocalcemia; Postoperative Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

• The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient

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

  Immediate (During total thyroidectomy procedure)

Secondary Outcomes (8)

• Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery

  5-14 days after surgery

• Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery

  Within 24-48 hours after surgery

• Blood Calcium Levels 24-48 Hours After Surgery

  Within 24-48 hours after surgery

• Duration in Minutes of Surgery

  Collected immediately following surgery

• Number of Frozen Section Analysis Performed.

  Collected immediately following surgery

Study Arms (2)

PTeye

EXPERIMENTAL

The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure.

Device: PTeye

Standard of Care

NO INTERVENTION

The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Interventions

PTeye DEVICE

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.

PTeye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
• Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

You may not qualify if:

• Pregnant women
• Patients with concurrent parathyroid and thyroid disease
• Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.
• Patients undergoing thyroid lobectomy or partial thyroidectomy

Sponsors & Collaborators

• University of Michigan: lead
• Vanderbilt University: collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, 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 Neoplasms; Thyroid Diseases; Hypoparathyroidism; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases

Limitations and Caveats

The median follow-up time of participants was 5-14 days post-operation. Therefore, we lack long-term follow-up (\> 6 months) for the majority of the participants.

Results Point of Contact

• Title: Dr. Paul Gauger
• Organization: University of Michigan Medical Center

pgauger@med.umich.edu

734-936-0231

Study Officials

• Paul Gauger, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 26, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)