Biop System's Safety and Performance

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04232865
• Other study ID #: CLP - 432
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: April 2021

Study information

• Verified date: January 2020
• Source: BIOP Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: April 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Device:
• Biop 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BIOP Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Performance	Incremental True positive (TP) rate and Incremental False positive (FP) rate	through study completion, an average of 1 year