CompletedNot Applicable

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

United States160 participantsStarted 2020-03-16

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 (PGs) during total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients 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

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

Timeframe: Immediate. During total thyroidectomy procedure.

Trial details

NCT IDNCT04281875

SponsorVanderbilt-Ingram Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-23

Results submitted2024-08-12

View on ClinicalTrials.gov More Postoperative Hypoparathyroidism trials