CompletedNot Applicable

Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

United States114 participantsStarted 2021-12-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland). * Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy. Exclusion Criteria: * Pregnant women * Patients with concurrent parathyroid and thyroid disease * Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure. * Patients undergoing thyroid lobectomy or partial thyroidectomy

What they're measuring

The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient

Timeframe: Immediate (During total thyroidectomy procedure)

Trial details

NCT IDNCT05022667

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

Results submitted2025-07-06

View on ClinicalTrials.gov More Thyroid Neoplasms trials