Back to resultsBiop System's Safety and Performance
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biop System
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bןםפ Sטדאקצ
Arm Description
Biop Colposcopy procedure
Outcomes
Primary Outcome Measures
SAE
The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).
Performance
Incremental True positive (TP) rate and Incremental False positive (FP) rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04232865
Brief Title
Biop System's Safety and Performance
Official Title
Biop System's Safety and Performance in Increased Detection of High-grade Lesions of the Cervical Epithelium in Women Scheduled for Colposcopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BIOP Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bןםפ Sטדאקצ
Arm Type
Experimental
Arm Description
Biop Colposcopy procedure
Intervention Type
Device
Intervention Name(s)
Biop System
Other Intervention Name(s)
Biop Colposcopy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
SAE
Description
The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).
Time Frame
through study completion, an average of 1 year
Title
Performance
Description
Incremental True positive (TP) rate and Incremental False positive (FP) rate
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Biop System's Safety and Performance
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