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

NCT03750214 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-01-18

No results posted yet for this study

Summary

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.

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 & Collaborators

  • BIOP Medical

    lead INDUSTRY

Principal Investigators

  • Ram Eitan, Md. · RMC Israel

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2020-11-30
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750214 on ClinicalTrials.gov