Cervical Cancer Screening Clinical Trial
Official title:
Bio Colposcopy System CIP: Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the
safety and performance of the Biop Digital Colposcope and the accuracy of the image
registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope
probe unit.
The Biop Digital Colposcope is intended for magnified viewing of the tissues of the vagina,
cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as
lesions or cancer, and selecting areas for biopsy. The images from the digital colposcope are
to be viewed on a color display. The digital colposcope is intended for use in hospitals,
clinics, and doctor's offices.
The Biop Micro Colposcope probe unit is an imaging tool intended to be placed in the vagina
for acquisition of images of the cervix. It is intended as an adjunct to the Biop Digital
Colposcope. It should NOT be used as a substitute for a thorough colposcopic evaluation. The
Biop Micro Colposcope Probe unit is not intended for use on the vulva and vagina.
It is anticipated that it will take approximately 3 months to complete active enrollment.
Study duration for each subject is 1-2 days, including screening, enrolment and procedure.
The study will be completed when the final study subject has completed the procedure.
1. Performance - to confirm that average image registration error is less than or equal to
(≤) 2mm.
2. Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing
cervical colposcopy procedures.
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