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

Last updated: September 27, 2023
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercalcemia

Parathyroid Disease

Parathyroid Disorders

Treatment

PTeye

Clinical Study ID

NCT05022641
HUM00192089
5R01CA212147-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary hyperparathyroidism who will be undergoing parathyroid surgery
  • Persistent primary hyperparathyroidism after having undergone a failed priorparathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion

Exclusion Criteria:

  • Pregnant women (Those patients who could potentially will receive preoperativepregnancy testing, as is standard before general anesthesia. Any patients withpositive pregnancy test results will not be included in the study.)
  • Patients with concurrent parathyroid and thyroid disease that require totalthyroidectomy
  • Patients with secondary or tertiary hyperparathyroidism

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: PTeye
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • The University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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