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

Completed · Not applicable

Conditions studied: Parathyroid Adenoma, Parathyroid Neoplasms, Parathyroid Cancer, Hypercalcemia, Primary Hyperparathyroidism

In brief

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.

Key facts

Study ID

NCT05022641

Run by

University of Michigan

People needed

160

Starts

2021-12-01

Expected to finish

2024-05-31

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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