Using near infrared autofluorescence to identify parathyroid glands during thyroid surgery
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
This study is testing a new device that uses special light to help surgeons find parathyroid glands during thyroid surgery to see if it can reduce complications for patients.
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 | NCT05022667 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of near infrared autofluorescence (NIRAF) detection using a device called 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It aims to determine if this technology improves outcomes compared to traditional surgeon detection methods. The study will compare risks and benefits in patients undergoing total thyroidectomy, assessing the impact of NIRAF on postoperative complications such as hypocalcemia and hypoparathyroidism.
Who should consider this trial
Good fit: Ideal candidates include patients with thyroid disease who are scheduled for total thyroidectomy, including those needing re-operative or completion thyroidectomy.
Not a fit: Patients who may not benefit include pregnant women, those with concurrent parathyroid and thyroid disease, or those undergoing thyroid lobectomy or partial thyroidectomy.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of postoperative complications related to parathyroid gland identification during thyroid surgery.
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: * Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland). * Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy. Exclusion Criteria: * Pregnant women * Patients with concurrent parathyroid and thyroid disease * Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure. * Patients undergoing thyroid lobectomy or partial thyroidectomy
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.