Use of the PTEye Device to Reduce Inadvertent Parathyroidectomy During Thyroid Surgery

NCT06927245 | Not Yet Recruiting DMC FDA Device

• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inadvertent Parathyroidectomy (IP) during thyroid surgery may lead to transient or permanent hypoparathyroidism and hypocalcemia, which represents significant morbidity. Patients that suffer from IP and its clinical consequences often require longer duration of hospitalization and additional inpatient treatment and prescription medications. ProMedica performs a large number of endocrine procedures, so the use of novel technology to aid in the intra operative identification of parathyroid glands may ultimately offer decreased morbidity to patients. The goal of this study is to find out if using the PTEye device (a device that uses infrared light to find the Parathyroid gland) lowers the amount of times a surgeon accidentally takes out the Parathyroid gland while trying to take out the Thyroid gland in surgery.

Conditions

Thyroid Surgery; Inadvertent Parathyroidectomy; Enlarged Thyroid

Keywords

PTEye; Total Thyroidectomy; Thyroid Lobectomy; Intraoperative Autofluorescence Imaging; Inadvertent Parathyroidectomy; Inadvertent Parathyroid Removal

Outcome Measures

Primary Outcomes (1)

• Rate of Inadvertent Parathyroidectomy

  The aim of this study is to establish the rate of inadvertent parathyroidectomy during thyroid surgery when the PTeye near-infrared device is used to aid with intraoperative identification of the parathyroid gland.

  From enrollment to one month after surgery

Study Arms (1)

Patients receiving Thyroid Surgery

EXPERIMENTAL

The experimental treatment group that is having either a Total Thyroidectomy or a Thyroid Lobectomy procedure done will have the PTEye device used in surgery to identify their Parathyroid Gland through autofluorescence.

Device: PTeye Device

Interventions

PTeye Device DEVICE

Near infrared stimulation of parathyroid tissue using light at a wavelength of approximately 690 - 770 nm results in autofluorescence of parathyroid tissue. Near infrared autofluorescence detection devices, such as PTEye have been developed with probe-based methods, displaying quantitative real-time information to aid surgeons in detection of parathyroid tissue relative to surrounding tissue.

Also known as: Intraoperative Autofluorescence Imaging

Patients receiving Thyroid Surgery

Eligibility Criteria

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

You may qualify if:

• Patients undergoing either a total thyroidectomy or a thyroid lobectomy
• Patients must be 18 years old or older
• Patient needs to be operated on by a study approved surgeon

You may not qualify if:

• Under 18 years old
• Receiving a planned parathyroidectomy, Cistrunk procedure, repeat neck surgery, or neck dissection
• Receiving surgery from a non-approved surgeon
• Pregnant at time of procedure

Sponsors & Collaborators

• ProMedica Health System: lead

MeSH Terms

Conditions

Goiter

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Leah Stevenson, MS

CONTACT

(419) 291-3491; Leah.Stevenson@promedica.org

Dawn Muskiewicz, MS

CONTACT

(419) 291-7517; Dawn.Muskiewicz@promedica.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 15, 2025
• Study Start: September 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share