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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases; Thyroid Diseases; Thyroid Neoplasms; Hypoparathyroidism
• Intervention / Treatment: Device: PTeye

Detailed Description

Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTeye; 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; 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.
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery	Blood parathyroid hormone (PTH) levels at 5-14 days post-op	5-14 days after surgery
Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours 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	Blood calcium levels 24-48 hours after surgery	Within 24-48 hours after surgery
Duration in Minutes of Surgery	Duration of surgery (minutes)	Collected immediately following surgery
Number of Frozen Section Analysis Performed.	Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.	Collected immediately following surgery
Number of Auto-transplanted Parathyroid Glands	Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.	Immediate. During total thyroidectomy procedure
Number of Nights Spent in the Hospital After Total Thyroidectomy	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.	0 - 4 nights after total thyroidectomy
Number of Inadvertently Resected Parathyroid Glands	Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. Results reflect the participants who had an inadvertently resected parathyroid gland.	Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Vanderbilt University
• Investigators: Principal Investigator: Paul Gauger, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Near Infrared Autofluorescence; Intraoperative Parathyroid Identification; Total Thyroidectomy; Postoperative Hypocalcemia; Postoperative Hypoparathyroidism
• Additional Relevant MeSH Terms: Thyroid Diseases; Neoplasms; Head and Neck Neoplasms; Hypoparathyroidism; Thyroid Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases
• Other Study ID Numbers: HUM00194322; R01CA212147 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes