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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer Screening
• Intervention / Treatment: Device: Biop Colposcopy System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Biop Coplposcopy System; Biop Colposcopy system procedure

Device: Biop Colposcopy System; The procedure stages: 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.; Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.; A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.; A questionnaire completed by the user after the Biop procedure, with regards to system usage; Image Registration analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint	Subject's comfort - as measured by a questionnaire	procedure day ± 1 day

Collaborators and Investigators

• Sponsor: BIOP Medical
• Investigators: Principal Investigator: Ram Eitan, Md., RMC Israel

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (ACTUAL): November 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CLP - 430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No