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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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

Study details

Parathyroid Adenoma, Parathyroid Neoplasms, Parathyroid Cancer, Hypercalcemia, Primary Hyperparathyroidism

NCT05022641

University of Michigan

27 January 2024

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