Biop System's Safety and Performance

Biop Medical

Status

Unknown

Conditions

Cervical Cancer

Treatments

Device: Biop System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04232865

CLP - 432

Details and patient eligibility

About

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

Full 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.

Enrollment

320 estimated patients

Sex

Female

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

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