Biop System's Safety and Performance

BIOP Medical320 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

320

Conditions

Cervical Cancer

Interventions

Biop SystemDEVICE

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.

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

SAE

The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).

Time frame: through study completion, an average of 1 year

Performance

Incremental True positive (TP) rate and Incremental False positive (FP) rate

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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