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Search / Trial NCT05022641

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

Launched by UNIVERSITY OF MICHIGAN · Aug 22, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Parathyroidectomy Intraoperative Parathyroid Identification Near Infrared Autofluorescence Persistent Hyperparathyroidism Persistent Hypercalcemia Failed Parathyroidectomy Repeat Parathyroidectomy

ClinConnect Summary

This clinical trial is examining whether a special tool called the Parathyroid Eye (PTeye), which uses near infrared autofluorescence (NIRAF) detection, can help surgeons identify parathyroid glands more effectively during surgery. The goal is to see if using this technology makes the surgery safer and more successful compared to relying solely on the surgeon's experience. The study will involve patients with conditions like primary hyperparathyroidism, which causes high levels of calcium in the blood, and who are scheduled for parathyroid surgery.

To participate in this trial, individuals must be diagnosed with primary hyperparathyroidism and be planning to undergo surgery. Those who have had unsuccessful parathyroid surgery in the past and require a repeat procedure may also be eligible. However, pregnant women, those needing thyroid surgery at the same time, or patients with other specific types of hyperparathyroidism will not be included. Participants can expect to be part of a study that may contribute to improving surgical outcomes for future patients, helping doctors better locate parathyroid glands during surgery.

Gender

ALL

Eligibility criteria

  • 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

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Paul Gauger

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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