Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Completed · Not applicable
Conditions studied: Postoperative Hypoparathyroidism, Thyroid Disease, Thyroid Neoplasms, Thyroid Cancer
In brief
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Key facts
- Study ID
- NCT05579782
- Run by
- Medical College of Wisconsin
- People needed
- 80
- Starts
- 2022-10-05
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2025-07-31
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- (i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).
- (ii) All patients undergoing completion thyroidectomy.
You may not qualify if…
- (i) Patients with concurrent parathyroid disease.
- (ii) Patients with incidental enlarged parathyroid discovered during TTx.
- (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
Where it is running
- Froedtert Hospital and Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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