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

NCT03750214 | Unknown

• 1 other identifier: CLP - 430
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Performance

  The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.

  procedure day ± 1 day

• frequency and incidence of all Adverse Events

  Safety endpoints include frequency and incidence of all Adverse Events (AE) and Serious Adverse Events (SAE) related and unrelated to the device use.

  procedure day ± 1 day

Other Outcomes (1)

• Exploratory Endpoint

  procedure day ± 1 day

Study Arms (1)

Biop Coplposcopy System

EXPERIMENTAL

Biop Colposcopy system procedure

Device: Biop Colposcopy System

Interventions

Biop Colposcopy System DEVICE

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

Biop Coplposcopy System

Eligibility Criteria

• Age: 22 Years - 65 Years
• Gender Eligibility Details: Females, ages 22 to 65 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females, ages 22 to 65 years old
• Referred for colposcopy, following abnormal cervical cytology
• Subject provides signed informed consent

You may not qualify if:

• Currently pregnant or nursing
• Currently menstruating
• Currently has intrauterine device (IUD)
• Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera.
• Diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system
• HIV-positive status
• Psychological instability, inappropriate attitude or motivation
• Use of any additional experimental drug or device or participation in another clinical study within the past 30 days

Sponsors & Collaborators

• BIOP Medical: lead

Study Officials

• Ram Eitan, Md.

  RMC Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Raveh Arbel

CONTACT

972528591891; dana@biopmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 21, 2018
• Study Start: May 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share