Biop System's Safety and Performance

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

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.

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