Circumcision, MaleNCT03761836
Evaluation and Adverse Event Surveillance for Initial Implementation of ShangRing Circumcision in Mozambique
A study testing ShangRing in people with Circumcision, Male, run by Jhpiego at 3 sites in Mozambique.
Trial summary
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for… Read more about this study
- Who is it for?
- Ages 13 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- ShangRing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesMozambique
- Study dates
- 1 Nov 2020to 30 Dec 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 13 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male, 13 years old and above
- Agrees to return to the facility where circumcision procedure is done for device removal on day 7 and to have home or off-site visits if deemed necessary by the ShangRing™ providers
- Is able and willing to provide a valid physical address of residence and at least one alternate address (address of employer, school, or friend/relative) for tracing
- Is able and willing to provide a valid primary phone number and at least one alternate phone number (phone number of friend/relative) and agrees to be contacted via that alternate number and person. This will facilitate telephone-based follow-up should he not return for the scheduled post-removal follow-up visits.
Who cannot join
- Males below 13 years of age
- Males for whom the correct fitting size of ShangRing™ Device is not available
- Anatomical abnormalities including adhesions
- Cognitive impairment
- Any health condition (reported or observed) that ShangRing™ providers deem a contraindication to the procedure. These may include history of diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness
- HIV - positive (although may still undergo surgical circumcision)
Show all 15Show fewer
- Anatomical variations and anomalies of genitalia
- Hypospadias, epispadias, or other urethral anomaly
- Hydrocele
- Scrotal hernia
- Other genital anomaly or disease including infectious or traumatic ulcers
- Dermatitis of the penis or foreskin
- Genital warts
- Urethral discharge
- Balanitis
Trial locations and contacts
3 sites in 1 country.
Mozambique3 sites
Infulene Psychiatric Hospital
Maputo
Matola II Health Center
Matola, Maputo Province
September 17 Health Center
Quelimane, Zambezia Province
About this study
Official title: Program Evaluation and Active Adverse Event Surveillance for Initial Implementation of WHO Prequalified ShangRing™ Circumcision in Mozambique
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are: 1) To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and 2) To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.
Read the detailed description
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are:
- To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and
- To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.
Population: 1000 males aged 13 years and above who are seeking male circumcision; 3 clinic sites
Duration: Approximately 3 months of recruitment, 60 days follow-up per participant; total duration expected to be approximately 6 months in the field.
Sample size: Cumulative target of 1000 ShangRing™ procedures, based on guidance contained in the WHO Framework for clinical evaluation of devices for male circumcision. The WHO TAG on Innovations in Male Circumcision recommends active follow-up of the first 1000 clients when a new device is introduced into a program or as a new program is implemented.
Data analysis plan: Baseline demographic and behavioral characteristics of ShangRing™ clients will be summarized using counts and percentages. Association between these variables and selected outcome variables (e.g. AEs, failure to return for device removal, preference for Shang Ring) will be examined through cross tabulations and tests of association (e.g. Chi square statistics).
Data quality assurance: Data quality control efforts will include members of the national VMMC Technical Working Group, including local ShangRing™ Trainers of Trainers, conducting scheduled site assessments/monitoring as follows: Prior to the start of the active surveillance (site initiation) using site assessment checklist; and every month using a VMMC quality assessment checklist. There will be regular monthly supervision visits to the facilities to ensure proper record filing and storage of physical forms. Data will be entered into an electronic system by trained data personnel at the facility level. This data will be reviewed actively and regularly through the central database on a periodic basis. The PI, lead local investigator and co-investigators will regularly monitor and evaluate data for completeness and specifically to monitor for any adverse events that may preclude or terminate the study early. The electronic system will be monitored regularly and by limited access of study personnel.
- Conditions
- Circumcision, Male
- Being tested
- ShangRing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShangRingDevice
The ShangRing™ is a device for male circumcision that was invented by Jian Zhong Shang and has been on the Chinese market since 2005. It consists of a sterile device with two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. It currently holds a European Conformity (CE) mark, an EN ISO certificate, and is FDA approved. Clinical data from ShangRing studies in Africa were reviewed by the WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision in January 2013 and were found to meet its clinical requirements. The ShangRing manufacturer was accepted by the WHO Prequalification Programme for Male Circumcision Devices in 2015.
| Study group | Role | What they receive |
|---|---|---|
| ShangRing | Experimental | Males aged 13 years and above will undergo circumcision through ShangRing procedure, with regular follow-up visits to evaluate pain, wound healing and incidence of adverse events. The ShangRing will be removed after 7 days, with a last follow-up visit at 60 days. Receives: Device: ShangRing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ShangRing clients who experience moderate and severe adverse events
Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions
Measured: 60 days postoperative
Secondary outcomes (3)
Proportion of eligible men who chose ShangRing procedure
ShangRing will be offered as a neutral alternative to conventional surgery or other available methods
Measured: Preoperative
Proportion of ShangRing™ clients who fail to return for device removal on day 7
Calculated by site and disaggregated by age group
Measured: 7 days postoperative
Pain scores on Visual Analog Scale
Peri- and post-operative pain scores as determined by visual analog scale
Measured: Within 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Nov 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: Funding no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision, MaleStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Mozambique, Centers for Disease Control and Prevention, Columbia University
- Responsible party
- Sponsor
- Investigators
- Edgar Necochea, MD, MPH, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761836
- Sponsor's protocol ID
- JHSPH IRB 8231
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Evaluation and Active Adverse Event Surveillance for Initial Implementation of WHO Prequalified ShangRing™ Circumcision in Mozambique
- ClinicalTrials.gov ID
- NCT03761836
- Acronym / sponsor ID
- JHSPH IRB 8231
- Conditions
- Circumcision, Male
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Ministry of Health, Mozambique, Centers for Disease Control and Prevention, Columbia University
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 3 Dec 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 single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are: 1) To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and 2) To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.
Detailed description
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and operational challenges and opportunities that may be associated with widespread use of ShangRing™ device for circumcision in different settings in Mozambique. Specific objectives are:
- To monitor the proportion of men who choose circumcision through the WHO-prequalified, FDA-approved ShangRing™ device in routine voluntary medical male circumcision (VMMC) service delivery settings where standard surgical methods of circumcisions are available; and
- To ensure safety during initial implementation of the ShangRing™ device and confirm that adverse event rates are comparable to those found during implementation in other sub-Saharan countries.
Population: 1000 males aged 13 years and above who are seeking male circumcision; 3 clinic sites
Duration: Approximately 3 months of recruitment, 60 days follow-up per participant; total duration expected to be approximately 6 months in the field.
Sample size: Cumulative target of 1000 ShangRing™ procedures, based on guidance contained in the WHO Framework for clinical evaluation of devices for male circumcision. The WHO TAG on Innovations in Male Circumcision recommends active follow-up of the first 1000 clients when a new device is introduced into a program or as a new program is implemented.
Data analysis plan: Baseline demographic and behavioral characteristics of ShangRing™ clients will be summarized using counts and percentages. Association between these variables and selected outcome variables (e.g. AEs, failure to return for device removal, preference for Shang Ring) will be examined through cross tabulations and tests of association (e.g. Chi square statistics).
Data quality assurance: Data quality control efforts will include members of the national VMMC Technical Working Group, including local ShangRing™ Trainers of Trainers, conducting scheduled site assessments/monitoring as follows: Prior to the start of the active surveillance (site initiation) using site assessment checklist; and every month using a VMMC quality assessment checklist. There will be regular monthly supervision visits to the facilities to ensure proper record filing and storage of physical forms. Data will be entered into an electronic system by trained data personnel at the facility level. This data will be reviewed actively and regularly through the central database on a periodic basis. The PI, lead local investigator and co-investigators will regularly monitor and evaluate data for completeness and specifically to monitor for any adverse events that may preclude or terminate the study early. The electronic system will be monitored regularly and by limited access of study personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ShangRing | Experimental | Device: ShangRingMales aged 13 years and above will undergo circumcision through ShangRing procedure, with regular follow-up visits to evaluate pain, wound healing and incidence of adverse events. The ShangRing will be removed after 7 days, with a last follow-up visit at 60 days. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male, 13 years old and above
- Agrees to return to the facility where circumcision procedure is done for device removal on day 7 and to have home or off-site visits if deemed necessary by the ShangRing™ providers
- Is able and willing to provide a valid physical address of residence and at least one alternate address (address of employer, school, or friend/relative) for tracing
- Is able and willing to provide a valid primary phone number and at least one alternate phone number (phone number of friend/relative) and agrees to be contacted via that alternate number and person. This will facilitate telephone-based follow-up should he not return for the scheduled post-removal follow-up visits.
Key exclusion criteria (15 listed)
- Males below 13 years of age
- Males for whom the correct fitting size of ShangRing™ Device is not available
- Anatomical abnormalities including adhesions
- Cognitive impairment
- Any health condition (reported or observed) that ShangRing™ providers deem a contraindication to the procedure. These may include history of diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness
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 |
|---|---|---|
| ShangRingThe ShangRing™ is a device for male circumcision that was invented by Jian Zhong Shang and has been on the Chinese market since 2005. It consists of a sterile device with two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. It currently holds a European Conformity (CE) mark, an EN ISO certificate, and is FDA approved. Clinical data from ShangRing studies in Africa were reviewed by the WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision in January 2013 and were found to meet its clinical requirements. The ShangRing manufacturer was accepted by the WHO Prequalification Programme for Male Circumcision Devices in 2015. | Device | ShangRing |
Primary outcome
Proportion of ShangRing clients who experience moderate and severe adverse events
Time frame: 60 days postoperative
Circumcision-related adverse events are classified as moderate and severe per standardized protocol definitions
3 secondary outcomes
Proportion of eligible men who chose ShangRing procedure
Time frame: Preoperative
Proportion of ShangRing™ clients who fail to return for device removal on day 7
Time frame: 7 days postoperative
Pain scores on Visual Analog Scale
Time frame: Within 48 hours postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Circumcision, Male
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Not yet recruiting
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
Circumcision
Not yet recruitingPhase 2
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
Posterior Urethral Valves
Recruiting
Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients
Circumcision, Ultrasound
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.
Edgar Necochea, MD, MPH principal investigator
Jhpiego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShangRing in people with Circumcision, Male, run by Jhpiego at 3 sites in Mozambique.
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mozambique. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of ShangRing clients who experience moderate and severe adverse events (time frame: 60 days postoperative). 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 22 Dec 2020.