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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PTeye Device
DeviceNear 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Patients receiving Thyroid SurgeryExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to one month after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: