Cervical Cancer
Conditions
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.
Interventions
DEVICEBiop System
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.
Sponsors
BIOP Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed