Using near infrared autofluorescence to identify parathyroid glands during surgery
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
This study is testing if a special light device can help surgeons find parathyroid glands more easily during surgery to improve patient outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05022641 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of near infrared autofluorescence (NIRAF) detection using the FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during parathyroidectomy procedures. It aims to determine if the use of NIRAF improves outcomes compared to traditional surgeon detection methods. The study will compare the risk-benefit profiles and surgical outcomes in patients undergoing parathyroid surgery with and without the use of NIRAF detection.
Who should consider this trial
Good fit: Ideal candidates include individuals with primary hyperparathyroidism or those undergoing repeat surgery for persistent primary hyperparathyroidism.
Not a fit: Patients with concurrent thyroid disease requiring total thyroidectomy or those with secondary or tertiary hyperparathyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved identification of parathyroid glands, reducing complications and improving surgical outcomes for patients with hyperparathyroidism.
How similar studies have performed: Other studies have shown promising results with similar intraoperative identification techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- The University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Paul Gauger — University of Michigan
- Study coordinator: Anee Sophia Jackson
- Email: aneesoph@med.umich.edu
- Phone: 734-647-1511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.