CompletedNot Applicable

Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy

United States160 participantsStarted 2020-03-13

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 parathyroidectomy (PTx) procedures. It compares risk-benefits and outcomes in PTx 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All primary hyperparathyroidism patients eligible for parathyroidectomy (PTx). Both bilateral and focused mode of PTx will be considered for this study, based on the surgeon's preference. * Re-operative primary hyperparathyroidism patients who have undergone a failed prior PTx. Exclusion Criteria: * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy. * Patients with secondary or tertiary hyperparathyroidism.

What they're measuring

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

Timeframe: Immediate. During PTx procedure.

Trial details

NCT IDNCT04299425

SponsorVanderbilt-Ingram Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-03

Results submitted2024-02-23

View on ClinicalTrials.gov More Parathyroid Adenoma trials