CompletedNot Applicable

Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy

United States80 participantsStarted 2022-10-05

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion Criteria: (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. Exclusion Criteria: (i) Patients with concurrent parathyroid disease. (ii) Patients with incidental enlarged parathyroid discovered during TTx. (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.

What they're measuring

Subjects With Transient Hypoparathyroidism.

Timeframe: 24-48 hours post-op

Patients With Hypoparathyroidism at Last Follow-up

Timeframe: 2 days to 1 year after surgery

Trial details

NCT IDNCT05579782

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-29

Results submitted2025-05-23

View on ClinicalTrials.gov More Postoperative Hypoparathyroidism trials