CompletedNot Applicable

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

United States160 participantsStarted 2021-12-01

Plain-language summary

This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

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: * Primary hyperparathyroidism who will be undergoing parathyroid surgery * Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: * Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.) * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy * Patients with secondary or tertiary hyperparathyroidism

What they're measuring

Average Number of Parathyroid Glands Identified

Timeframe: Measured within the procedure, generally not more than 2 hours

Trial details

NCT IDNCT05022641

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

Results submitted2025-08-08

View on ClinicalTrials.gov More Parathyroid Adenoma trials