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

Last updated: August 8, 2025
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

Condition

Parathyroid Disorders

Hypercalcemia

Parathyroid Cancer

Treatment

PTeye

Standard of Care

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.

Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

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): 2
Primary Treatment: PTeye
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
May 31, 2024

Study Description

Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

Connect with a study center

  • The University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • The University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

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