Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)

NAUnknownINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 31, 2020

Primary Completion Date

November 30, 2020

Study Completion Date

December 31, 2020

Conditions
Cervical Cancer Screening
Interventions
DEVICE

Biop Colposcopy System

"The procedure stages:~1. Scanning of the cervix - the cervix is scanned using the micro colposcope probe unit, to produce a total of 51 micro-images and one macro image from the panoramic camera.~2. Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.~3. A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.~4. A questionnaire completed by the user after the Biop procedure, with regards to system usage~5. Image Registration analysis"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BIOP Medical

INDUSTRY

NCT03750214 - Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure) | Biotech Hunter | Biotech Hunter