Cervical CancerNCT04232865
Biop System's Safety and Performance
A study testing Biop System in people with Cervical Cancer, run by BIOP Medical.
Trial summary
Biop system's safety and performance in increased detection of High-Grade lesions of the cervical epithelium in women scheduled for colposcopy Read more about this study
- Who is it for?
- Ages 22 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Biop System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Apr 2021
- 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
- Female Age ≥ 22 years and ≤ 65.
- Referred for colposcopy, following abnormal cervical cytology;
- Participant provides signed informed consent
Who cannot join
- 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.
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- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Biop System
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biop SystemDevice
Also called Biop Colposcopy 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.
| Study group | Role | What they receive |
|---|---|---|
| Bןםפ Sטדאקצ | Experimental | Biop Colposcopy procedure Receives: Device: Biop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE
The primary safety endpoint will be consisted of frequency and incidence of all Device Related Adverse Events (AE) and Serious Adverse Events (SAE).
Measured: through study completion, an average of 1 year
Performance
Incremental True positive (TP) rate and Incremental False positive (FP) rate
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startJun 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BIOP Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232865
- Sponsor's protocol ID
- CLP - 432
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- 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
- Biop System's Safety and Performance in Increased Detection of High-grade Lesions of the Cervical Epithelium in Women Scheduled for Colposcopy
- ClinicalTrials.gov ID
- NCT04232865
- Acronym / sponsor ID
- CLP - 432
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- BIOP MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bןםפ Sטדאקצ | Experimental | Device: Biop SystemBiop Colposcopy 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)
- Female Age ≥ 22 years and ≤ 65.
- Referred for colposcopy, following abnormal cervical cytology;
- Participant provides signed informed consent
Key exclusion criteria (14 listed)
- 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,
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 SystemAlso: Biop Colposcopy SystemStage 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. | Device | Bןםפ Sטדאקצ |
Primary outcome
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).
Performance
Time frame: through study completion, an average of 1 year
Incremental True positive (TP) rate and Incremental False positive (FP) rate
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Biop System in people with Cervical Cancer, 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 14 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAE (time frame: through study completion, an average of 1 year). 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.