CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
PTeyedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05022667
NCT05022667N/ACompleted
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Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

University of Michigan·interventional·Posted Aug 26, 2021·Updated Aug 8, 2025

In Brief

A clinical study evaluating PTeye for Thyroid Neoplasms and 8 related conditions. Completed, enrolled 114 participants across 1 site.

Detailed Summary

This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Neoplasms, Thyroid Diseases, Hypoparathyroidism, Endocrine System Diseases, Endocrine Gland Neoplasms, Neoplasms by Site, Neoplasms, Head and Neck Neoplasms, Parathyroid Diseases
CountriesUnited States
CollaboratorsVanderbilt University

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 26, 2021
Enrollment StartDec 1, 2021
Primary CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.9 years ago

Interventions

PTeyedevice

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.