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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorProMedica Health System

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PTeye Device

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators