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

NCT ID: NCT06927245

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Thyroid Surgery; Inadvertent Parathyroidectomy; Enlarged Thyroid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PTeye Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Intraoperative Autofluorescence Imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ProMedica Health System

OTHER

Sponsor Role: lead

Responsible Party

Joseph Sferra

Professor, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Leah Stevenson, MS

Role: CONTACT

Leah.Stevenson@promedica.org

(419) 291-3491

Dawn Muskiewicz, MS

Role: CONTACT

Dawn.Muskiewicz@promedica.org

(419) 291-7517