Male CircumcisionRMC-05NCT02281435
Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects
A study testing PrePex™ device in people with Male Circumcision and HIV Prevention, run by Ministry of Health, Rwanda at 1 site in Rwanda.
Trial summary
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60% and by up to 73% in post-trial observation. Read more about this study
- Who is it for?
- Ages 21 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision, HIV Prevention, Screen Failure Subjects
- What is being tested?
- PrePex™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRwanda
- Study dates
- Nov 2012to Jun 2013
- 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 21 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages - 21 to 49 years
- Subject wants to be circumcised
- Uncircumcised
- HIV sero-negative
- Able to understand the study procedures and requirements
- Agrees to abstain sexual intercourse for 9 weeks
Show all 12Show fewer
- Agrees to abstain from masturbation for 2 weeks
- Agrees to remain in the health care facility for up to 48 hours post procedure as required
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
- Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
- Subject agrees to anonymous video and photographs of the procedure and follow up visits
- Subject that was a medical screen failure in RMC-03 study.
Who cannot join
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision according to the study procedure and can only undergo surgical MC
- HIV sero-positive
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- Refusal to take HIV test
- Refuse to be hospitalized in the medical center for up to 48 hours post Placement as required
- Subjects that should be excluded from standard surgical MC, such as warts under the prepuce, hypospadias, epispadias, un treated UTI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-arm, Open Label, Phase I (Out of 3 Phases), Pilot Study to Verify the Safety of PrePex™ Device for Screen Failure Subjects (Men With Narrow Foreskin and Phimosis) for Adult Male Circumcision, Performed by Physicians, in a Male Population That is Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV.
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60% and by up to 73% in post-trial observation. Numerous papers on the topic have been published over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan countries.
Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011, suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80% coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up would result in averting 3.36 million new HIV infections through 2025. In addition, while the model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it would result in net savings (due to averted treatment and care costs) amounting to US$16.51 billion.
To date, there are over 38 million adolescent and adult males in Africa that could benefit from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resource limited settings.
Read the detailed description
Rwanda has a national plan to offer a Voluntary Medical Male Circumcision (VMMC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy.
The PrePex device was granted with pre-qualification approval on May 2013 by the World Health Organization (WHO), for scaling up VMMC in Africa.
The device works by stopping the flow of blood to the distal foreskin, leading to necrosis of the tissue, which is removed with the device after 7 days.
The PrePex device was developed to facilitate rapid scale up of non-surgical adult male circumcision in resource limited settings, and it is the first MC device which was granted with a WHO recommendation in addition to CE and FDA approvals.
Prior studies showed that between 8%-12% of men are contraindicated for the standard PrePex technique due to very narrow foreskin from border cases to severe Phimosis, preventing insertion of the Inner Ring of the PrePex device.
The main objective of the study was to test the safety of a new male circumcision technique, using the same PrePex device (PrePex with incision). The new technique entails the use of local anesthesia and thereafter an incision in the foreskin. PrePex with incision technique was planned to allow PrePex non-surgical contraindicated patients to undergo VMMC with the device, thus avoiding conventional surgery and suturing. The study also included analysis of potential benefits the PrePex with incision technique has over conventional surgical circumcision.
The study has 3 phases, the current results represent Phase I - testing the feasibility and safety of the PrePex with incision procedure, intended to screen failure subjects of the standard PrePex procedure. Phase I includes performing feasibility testing on 6 subjects using 2 different techniques and once feasibility is demonstrated to include an additional Analysis phase of data collection from additional 30 subjects to reinforce the safety of the one chosen technique.
Phase II will includes a special non-surgical PrePex procedure for patients with narrow foreskin that will entail the usage of Lidocaine anesthetic cream 30 minutes pre procedure and additional force in inserting of the Inner Ring (hereto: Special PrePex procedure).
Phase III will includes performing additional PrePex with incision procedures with local anesthesia and special PrePex procedure incision to achieve a statistical significant sample size and determine the recommended guideline and procedure for performing PrePex on men with narrow foreskin and phimosis.
- Being tested
- PrePex™ device
- Keywords
- Male Circumcision, HIV Prevention, Screen Failure Subjects, PrePex with Incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePex™ deviceDevice
PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures, but in this study the procedure consist an incision on to the foreskin.
| Study group | Role | What they receive |
|---|---|---|
| PrePex with Incision | Experimental | Adult male circumcision by the PrePex™ device using foreskin incision Receives: Device: PrePex™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical Adverse Events (AEs)
To verify that the incidence of moderate and severe Clinical AEs and device-related Adverse Events are not significantly higher than 2%.
Measured: 11 months
Secondary outcomes (5)
Rate of complete circumcision
Glans fully exposed
Measured: 11 months
Time to complete healing
Average time to complete healing
Measured: 11 months
Device related incidents
Necrotic Process not initiated, i.e the device does not perform according to its intended use of stopping blood flow to the foreskin.
- Device does not remain in situ. (a case where subject is not compliance with counseling instructions and actively moves the device from its place, will not be considered a device related incident)
Measured: 11 months
Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin.
Technique 1 Vs. technique 2
Measured: 11 months
Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum
Device safety was assessed by the rate of clinical adverse events and device-related incidents.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male CircumcisionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vincent Mutabazi, Ministry of Health, Rwanda
- Investigators
- Vincent Mutabazi, M.D., Principal investigator, Ministry of Health, RwandaJean Paul Bitega, M.D., Principal investigator, Rwanda Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281435
- Sponsor's protocol ID
- RMC-05 (Phase I)
- Acronym
- RMC-05
- Status last verified
- Oct 2014
- First submitted
- 22 May 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Open Label, Phase I (Out of 3 Phases), Pilot Study to Verify the Safety of PrePex™ Device for Screen Failure Subjects (Men With Narrow Foreskin and Phimosis) for Adult Male Circumcision, Performed by Physicians, in a Male Population That is Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV.
- ClinicalTrials.gov ID
- NCT02281435
- Acronym / sponsor ID
- RMC-05 / RMC-05 (Phase I)
- Keywords
- Male Circumcision, HIV Prevention, Screen Failure Subjects, PrePex with Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Nov 2014 (estimated)
- 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.
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60% and by up to 73% in post-trial observation. Numerous papers on the topic have been published over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan countries.
Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011, suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80% coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up would result in averting 3.36 million new HIV infections through 2025. In addition, while the model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it would result in net savings (due to averted treatment and care costs) amounting to US$16.51 billion.
To date, there are over 38 million adolescent and adult males in Africa that could benefit from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resource limited settings.
Detailed description
Rwanda has a national plan to offer a Voluntary Medical Male Circumcision (VMMC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy.
The PrePex device was granted with pre-qualification approval on May 2013 by the World Health Organization (WHO), for scaling up VMMC in Africa.
The device works by stopping the flow of blood to the distal foreskin, leading to necrosis of the tissue, which is removed with the device after 7 days.
The PrePex device was developed to facilitate rapid scale up of non-surgical adult male circumcision in resource limited settings, and it is the first MC device which was granted with a WHO recommendation in addition to CE and FDA approvals.
Prior studies showed that between 8%-12% of men are contraindicated for the standard PrePex technique due to very narrow foreskin from border cases to severe Phimosis, preventing insertion of the Inner Ring of the PrePex device.
The main objective of the study was to test the safety of a new male circumcision technique, using the same PrePex device (PrePex with incision). The new technique entails the use of local anesthesia and thereafter an incision in the foreskin. PrePex with incision technique was planned to allow PrePex non-surgical contraindicated patients to undergo VMMC with the device, thus avoiding conventional surgery and suturing. The study also included analysis of potential benefits the PrePex with incision technique has over conventional surgical circumcision.
The study has 3 phases, the current results represent Phase I - testing the feasibility and safety of the PrePex with incision procedure, intended to screen failure subjects of the standard PrePex procedure. Phase I includes performing feasibility testing on 6 subjects using 2 different techniques and once feasibility is demonstrated to include an additional Analysis phase of data collection from additional 30 subjects to reinforce the safety of the one chosen technique.
Phase II will includes a special non-surgical PrePex procedure for patients with narrow foreskin that will entail the usage of Lidocaine anesthetic cream 30 minutes pre procedure and additional force in inserting of the Inner Ring (hereto: Special PrePex procedure).
Phase III will includes performing additional PrePex with incision procedures with local anesthesia and special PrePex procedure incision to achieve a statistical significant sample size and determine the recommended guideline and procedure for performing PrePex on men with narrow foreskin and phimosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrePex with Incision | Experimental | Device: PrePex™ deviceAdult male circumcision by the PrePex™ device using foreskin incision |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Ages - 21 to 49 years
- Subject wants to be circumcised
- Uncircumcised
- HIV sero-negative
- Able to understand the study procedures and requirements
Key exclusion criteria (7 listed)
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision according to the study procedure and can only undergo surgical MC
- HIV sero-positive
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- Refusal to take HIV test
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 |
|---|---|---|
| PrePex™ devicePrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures, but in this study the procedure consist an incision on to the foreskin. | Device | PrePex with Incision |
Primary outcome
Rate of clinical Adverse Events (AEs)
Time frame: 11 months
To verify that the incidence of moderate and severe Clinical AEs and device-related Adverse Events are not significantly higher than 2%.
5 secondary outcomes
Rate of complete circumcision
Time frame: 11 months
Time to complete healing
Time frame: 11 months
Device related incidents
Time frame: 11 months
Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin.
Time frame: 11 months
Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum
Time frame: 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Rwanda Biomedical CentreLink provided by the sponsor.
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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.
Vincent Mutabazi, M.D. principal investigator
Ministry of Health, Rwanda
Jean Paul Bitega, M.D. principal investigator
Rwanda Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrePex™ device in people with Male Circumcision and HIV Prevention, run by Ministry of Health, Rwanda at 1 site in Rwanda.
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 12 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of clinical Adverse Events (AEs) (time frame: 11 months). 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 3 Nov 2014.