Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy

NACompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

March 13, 2020

Primary Completion Date

March 3, 2023

Study Completion Date

March 3, 2023

Conditions
Parathyroid AdenomaParathyroid NeoplasmsParathyroid HyperplasiaParathyroid CancerHypercalcemiaPrimary Hyperparathyroidism
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."

Trial Locations (1)

37212

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT04299425 - Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy | Biotech Hunter | Biotech Hunter