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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• (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.

Locations
United States
Wisconsin
Froedtert Hospital and Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: 2022-10-05
Completion Date: 2024-12-31
Participants
Target number of participants: 80
Treatments
Experimental: NIRAF Detection Technology (+)
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
No_intervention: NIRAF Detection Technology (-)
Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
Sponsors
Leads: Medical College of Wisconsin
Collaborators: Vanderbilt University, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov