Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
NCT ID: NCT03750214
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
26 participants
INTERVENTIONAL
2020-05-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Biop System's Safety and Performance
NCT04232865
Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
NCT05851079
Internet-Based Cervical Cytology Screening Program
NCT00658190
Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
NCT04072913
Comparison of Screening Tests in Detecting Cervical Neoplasia
NCT00039312
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Biop Digital Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the digital colposcope are to be viewed on a color display. The digital colposcope is intended for use in hospitals, clinics, and doctor's offices.
The Biop Micro Colposcope probe unit is an imaging tool intended to be placed in the vagina for acquisition of images of the cervix. It is intended as an adjunct to the Biop Digital Colposcope. It should NOT be used as a substitute for a thorough colposcopic evaluation. The Biop Micro Colposcope Probe unit is not intended for use on the vulva and vagina.
It is anticipated that it will take approximately 3 months to complete active enrollment. Study duration for each subject is 1-2 days, including screening, enrolment and procedure. The study will be completed when the final study subject has completed the procedure.
1. Performance - to confirm that average image registration error is less than or equal to (≤) 2mm.
2. Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing cervical colposcopy procedures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biop Coplposcopy System
Biop Colposcopy system procedure
Biop Colposcopy System
The procedure stages:
1. Scanning of the cervix - the cervix is scanned using the micro colposcope probe unit, to produce a total of 51 micro-images and one macro image from the panoramic camera.
2. Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.
3. A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.
4. A questionnaire completed by the user after the Biop procedure, with regards to system usage
5. Image Registration analysis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biop Colposcopy System
The procedure stages:
1. Scanning of the cervix - the cervix is scanned using the micro colposcope probe unit, to produce a total of 51 micro-images and one macro image from the panoramic camera.
2. Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.
3. A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.
4. A questionnaire completed by the user after the Biop procedure, with regards to system usage
5. Image Registration analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Referred for colposcopy, following abnormal cervical cytology
* Subject provides signed informed consent
Exclusion Criteria
* Currently menstruating
* Currently has intrauterine device (IUD)
* Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera.
* Diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system
* HIV-positive status
* Psychological instability, inappropriate attitude or motivation
* Use of any additional experimental drug or device or participation in another clinical study within the past 30 days
22 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BIOP Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ram Eitan, Md.
Role: PRINCIPAL_INVESTIGATOR
RMC Israel
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLP - 430
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.