Biop System's Safety and Performance

NCT04232865 | Unknown

• 1 other identifier: CLP - 432
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Performance

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

  through study completion, an average of 1 year

Study Arms (1)

Bןםפ Sטדאקצ

EXPERIMENTAL

Biop Colposcopy procedure

Device: Biop System

Interventions

Biop System DEVICE

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.

Also known as: Biop Colposcopy System

Bןםפ Sטדאקצ

Eligibility Criteria

• Age: 22 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Age ≥ 22 years and ≤ 65.
• Referred for colposcopy, following abnormal cervical cytology;
• Participant provides signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• BIOP Medical: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: June 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share