Biop System's Safety and Performance

Not Applicable

• Conditions: Cervical Cancer
• Interventions: Device: Biop System

• Registration Number: NCT04232865
• Lead Sponsor: BIOP Medical

Brief Summary

Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy

Detailed Description

Biop system's safety and performance in increased detection of high-grade lesions of the cervical epithelium in women scheduled for colposcopy.

This is a multi-center, prospective, open label, non-randomized study to train the Biop System's algorithm and evaluate the safety and performance of the Biop system in women undergoing cervical colposcopy.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Study Start: 2020-06
• Primary Completion: 2021-01
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

• Female Age ≥ 22 years and ≤ 65.
• Referred for colposcopy, following abnormal cervical cytology;
• Participant provides signed informed consent

Exclusion Criteria

• Currently pregnant (through six weeks postpartum) or nursing
• Currently menstruating
• Previous hysterectomy
• Currently has intrauterine device (IUD)
• Cervical biopsy or therapeutic procedure since the referral cervical cytology,
• Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycythemia vera.
• Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) (Applicable to training stage only)
• A known latex allergy
• Psychological instability, inappropriate attitude or motivation
• Cervical cytology tests within the prior seven days
• Use of vaginal medications within the last 48 h or photosensitizing agents within 72 h
• History of photosensitivity or other diseases affected by UV radiation,
• An observable and untreated gynecological infection.
• Previous history of CIN therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bןםפ Sטדאקצ	Biop System	Biop Colposcopy procedure

Primary Outcome Measures

Name	Time	Method
SAE	through study completion, an average of 1 year	The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).
Performance	through study completion, an average of 1 year	Incremental True positive (TP) rate and Incremental False positive (FP) rate