Trials / Not Yet Recruiting

Not Yet RecruitingNCT06927245

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

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 25 (estimated)

Sponsor: ProMedica Health System · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-09-01
Primary completion: 2025-11-30
Completion: 2025-12-31
First posted: 2025-04-15
Last updated: 2025-08-11

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06927245. Inclusion in this directory is not an endorsement.