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

August 5, 2025 updated by: Joseph Sferra, ProMedica Health System

Use of Intraoperative Autofluorescence Imaging to Reduce the Incidence of Inadvertent Parathyroidectomy During Thyroid Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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 investigators plan to prospectively enroll 25 patients undergoing either thyroid lobectomy or total thyroidectomy. The surgeries will be performed by study approved surgeons. All surgeries will take place over a 90 day period beginning at the receipt of the PTEye device. All subjects will be consented pre-operatively for enrollment in the study, including consent for use of the PTeye device. Subjects undergoing a planned parathyroidectomy, Cistrunk procedure, repeat neck surgery, or neck dissection will not be included in this particular study.

Subjects will not have any changes in their pre-surgical procedure. Subjects will follow typical standard of care procedures for surgery. Once the subject is in surgery, the surgeon will use the PTeye device to identify the parathyroid gland. Using the disposable probe to make contact with the tissue, the surgeon will scan the thyroid for a baseline reading. Once the surgeon has established a baseline, they are able to use the device to confirm whether the tissue they identified is parathyroid tissue. The device will make a noise when it detects parathyroid tissue. Other than the use of the PTeye device, the surgeons will follow standard of care procedures to perform the surgery. The subject will follow standard of care post-operative procedures and will not be required to attend any additional appointments (other than those scheduled per standard of care).

The investigators will extract multiple data points from these 25 subjects. The primary endpoint will be the rate of inadvertent parathyroidectomy. This will be identified by review of surgical pathology reports for parathyroid tissue. Secondary endpoints include the number of frozen sections sent, number of autotransplantations of parathyroid tissue performed, operative times, and post operative Parathyroid Hormone and Calcium levels. These data points will be collected by chart review. Each subject will follow up two weeks post operatively, per standard of care procedure. We plan to follow patients for one month post operatively to monitor for any pertinent hospital readmissions by performing a chart review of the patient.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving Thyroid Surgery
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
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.
Other Names:
  • Intraoperative Autofluorescence Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Inadvertent Parathyroidectomy
Time Frame: From enrollment to one month after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProMedica Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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