Biop System's Safety and Performance

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

Detailed Description
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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.

Official Title
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Biop System's Safety and Performance in Increased Detection of High-grade Lesions of the Cervical Epithelium in Women Scheduled for Colposcopy

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Biop System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bןםפ Sטדאקצ<br>Biop Colposcopy procedure | Device: Biop System<br>* Stage 1 - Training: Up to 320 women in whom a complete procedure with the Biop System will be performed. Biopsies will be taken solely based on colposcopy examination. Enrolled participants will include at least 80 participants Histopathology identified with a high-grade lesion and at least 80 participants Histopathology identified as normal or with a low-grade lesion. Stage 2 - Validation: Up to 330 HIV negative women in whom a complete procedure with the Biop System will be performed. Validation stage will also include up to 165 HIV positive participants. All participants will be enrolled in up to 3 sites in South Africa.<br>* Other names: Biop Colposcopy System;|

What is the study measuring?
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Primary Outcome Measures

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