Cervical Cancer ScreeningNCT03750214
Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
A study testing Biop Colposcopy System in people with Cervical Cancer Screening, run by BIOP Medical.
Trial summary
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit. Read more about this study
- Who is it for?
- Ages 22 to 65 years, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Biop Colposcopy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, ages 22 to 65 years old
- Referred for colposcopy, following abnormal cervical cytology
- Subject provides signed informed consent
Who cannot join
- Currently pregnant or nursing
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bio Colposcopy System CIP: Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
Read the detailed description
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
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.
- Performance - to confirm that average image registration error is less than or equal to (≤) 2mm.
- Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing cervical colposcopy procedures.
- Conditions
- Cervical Cancer Screening
- Being tested
- Biop Colposcopy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biop Colposcopy SystemDevice
The procedure stages:
- 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.
- Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.
- A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.
- A questionnaire completed by the user after the Biop procedure, with regards to system usage
- Image Registration analysis
| Study group | Role | What they receive |
|---|---|---|
| Biop Coplposcopy System | Experimental | Biop Colposcopy system procedure Receives: Device: Biop Colposcopy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.
Measured: procedure day ± 1 day
frequency and incidence of all Adverse Events
Safety endpoints include frequency and incidence of all Adverse Events (AE) and Serious Adverse Events (SAE) related and unrelated to the device use.
Measured: procedure day ± 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study startMay 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BIOP Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ram Eitan, Md., Principal investigator, RMC Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750214
- Sponsor's protocol ID
- CLP - 430
- Status last verified
- Jan 2020
- First submitted
- 14 Nov 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio Colposcopy System CIP: Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
- ClinicalTrials.gov ID
- NCT03750214
- Acronym / sponsor ID
- CLP - 430
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- BIOP MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
Detailed description
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.
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.
- Performance - to confirm that average image registration error is less than or equal to (≤) 2mm.
- Safety - to evaluate the safety of the Biop Digital Colposcope in women undergoing cervical colposcopy procedures.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biop Coplposcopy System | Experimental | Device: Biop Colposcopy SystemBiop Colposcopy system procedure |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females, ages 22 to 65 years old
- Referred for colposcopy, following abnormal cervical cytology
- Subject provides signed informed consent
Key exclusion criteria (8 listed)
- Currently pregnant or nursing
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biop Colposcopy SystemThe 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 | Device | Biop Coplposcopy System |
Primary outcome
Performance
Time frame: procedure day ± 1 day
The primary performance endpoint is the image registration success. Image registration success is defined by the registration error (distance between corresponding control points following registration). Average image registration error should be less than or equal to (≤) to 2mm.
frequency and incidence of all Adverse Events
Time frame: procedure day ± 1 day
Safety endpoints include frequency and incidence of all Adverse Events (AE) and Serious Adverse Events (SAE) related and unrelated to the device use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram Eitan, Md. principal investigator
RMC Israel
Questions about this trial
What is this clinical trial studying?
A study testing Biop Colposcopy System in people with Cervical Cancer Screening, run by BIOP Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Raveh Arbel (972528591891, dana@biopmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: procedure day ± 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.