Biop System's Safety and Performance

January 16, 2020 updated by: BIOP Medical

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bןםפ Sטדאקצ
Biop Colposcopy procedure
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.

Other Names:
  • Biop Colposcopy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAE
Time Frame: 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).
through study completion, an average of 1 year
Performance
Time Frame: through study completion, an average of 1 year
Incremental True positive (TP) rate and Incremental False positive (FP) rate
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BIOP Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP - 432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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