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

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 5, 2022

Primary Completion Date

May 29, 2024

Study Completion Date

December 31, 2024

Conditions
Postoperative HypoparathyroidismThyroid DiseaseThyroid NeoplasmsThyroid Cancer
Interventions
DEVICE

NIRAF Detection Technology

"Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).~After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.~Other Name: PTeye Device"

Trial Locations (1)

53226

Froedtert Hospital and Medical College of Wisconsin, Milwaukee

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Vanderbilt University

OTHER

lead

Medical College of Wisconsin

OTHER