Circumcision, MalePhase 2/3NCT01300910
Comparison of the Shang Ring With Conventional Surgical Methods
A Phase 2/3 study testing Shang Ring and Male circumcision in people with Circumcision, Male, run by FHI 360 at 2 sites in 2 countries.
Trial summary
This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia). Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Shang Ring and Male circumcision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2011to Jun 2011
- Phase
- Phase 2/3
- 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 18 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must be HIV sero-negative, with documentation of testing no more than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
- Must be able to understand study procedures and requirements of study participation;
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- Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;
- Must freely consent to participate in the study and sign a written informed consent form;
- Must have a cell phone or access to a cell phone; and,
- Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
Who cannot join
- Has a known allergy or sensitivity to lidocaine or other local anesthesia;
- Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- Has known bleeding/clotting disorder (e.g. hemophilia); or
- Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study;
- Is not currently participating in another biomedical study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Kenya1 site
Homa Bay District Hospital male circumcision clinic
Homa Bay, Nyanza, 40300
About this study
Official title: Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial
This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).
Read the detailed description
A randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia)
Population: 400 men (200 at each site), HIV sero-negative men, ages 18-54, living in/around the two clinic sites seeking adult male circumcision
Duration: 2-4 months of recruitment; 60 days follow-up per participant; total expected duration of approximately 6 months in the field
Primary Objectives: (1) Compare the pain and acceptability of the Shang Ring procedure with the forceps guided surgical circumcision technique (Kenya) and the dorsal slit technique (Zambia) (2) Compare the safety and the course of wound healing, including the time to complete healing, between the Shang Ring adult male circumcision procedure and the standard surgical circumcision procedures (forceps guided in Kenya \& dorsal slit in Zambia); (3) Compare the ease of the Shang Ring method versus standard circumcision surgical procedures
Primary Endpoints: (1) To compare the pain \& acceptability of the circumcision methods, we will evaluate the following: post-operative pain; time to return to normal activity; patients' opinions of the Shang Ring and conventional procedures, and satisfaction with cosmetic results.
(2) To compare safety between methodologies, we will clinically compare and evaluate related adverse events and their severity. We will also compare the time to complete wound healing for each method. Complete wound healing is defined as no scab and dry skin by clinical assessment.
(3) We will evaluate the ease of surgery based on the duration of surgery and surgeons' opinions.
- Conditions
- Circumcision, Male
- Being tested
- Shang Ring, Male circumcision
- Keywords
- Adult Males, Circumcision, HIV prevention, Device, Shang Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shang RingDevice
The Shang Ring is a sterile device consisting of 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. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing
Male circumcisionProcedure or surgery
A conventional surgical procedure will be performed, per WHO recommendations, involving: drawing a line to mark the amount of foreskin to be cut; cutting off the foreskin; hemostasis; and wound closure with sutures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | One group of men will undergo a circumcision using the Shang Ring and men are to return for regular follow-up visits to evaluate pain and wound healing. . The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 60 days. Receives: Device: Shang Ring |
| 2 | Active comparator | One group of men will undergo a conventional circumcision using a WHO recommended surgical technique, either the forceps-guided method or the dorsal slit method. Men are to return for regular follow-up visits to evaluate pain and wound healing, with the last scheduled follow-up visit at 60 days. Receives: Procedure: Male circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the Visual Analog Scale
We will ask participants about pain they experienced during and soon after the procedure, and during the recovery period.
Measured: Within the first 48 hours after circumcision
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
We will classify circumcision-related adverse events, using the detailed definitions of moderate and severe events per standardized protocol definitions, based on WHO recommendations. Most post-operative complications are apparent within six weeks of surgery.
Measured: Up to six weeks after surgery
Secondary outcomes (1)
Compare the cost of the Shang Ring procedure versus conventional surgery
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- EngenderHealth, Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, University Teaching Hospital, Lusaka, Zambia
- Responsible party
- Sponsor
- Investigators
- Marc Goldstein, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300910
- Sponsor's protocol ID
- 10220
- Status last verified
- Mar 2012
- First submitted
- 7 Sep 2010
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions. Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.
PubMed 33786810
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01300910
- Acronym / sponsor ID
- 10220
- Conditions
- Circumcision, Male
- Keywords
- Adult Males, Circumcision, HIV prevention, Device, Shang Ring
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- EngenderHealth, Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, University Teaching Hospital, Lusaka, Zambia
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Feb 2011 (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.
This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).
Detailed description
A randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia)
Population: 400 men (200 at each site), HIV sero-negative men, ages 18-54, living in/around the two clinic sites seeking adult male circumcision
Duration: 2-4 months of recruitment; 60 days follow-up per participant; total expected duration of approximately 6 months in the field
Primary Objectives: (1) Compare the pain and acceptability of the Shang Ring procedure with the forceps guided surgical circumcision technique (Kenya) and the dorsal slit technique (Zambia) (2) Compare the safety and the course of wound healing, including the time to complete healing, between the Shang Ring adult male circumcision procedure and the standard surgical circumcision procedures (forceps guided in Kenya \& dorsal slit in Zambia); (3) Compare the ease of the Shang Ring method versus standard circumcision surgical procedures
Primary Endpoints: (1) To compare the pain \& acceptability of the circumcision methods, we will evaluate the following: post-operative pain; time to return to normal activity; patients' opinions of the Shang Ring and conventional procedures, and satisfaction with cosmetic results.
(2) To compare safety between methodologies, we will clinically compare and evaluate related adverse events and their severity. We will also compare the time to complete wound healing for each method. Complete wound healing is defined as no scab and dry skin by clinical assessment.
(3) We will evaluate the ease of surgery based on the duration of surgery and surgeons' opinions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Shang RingOne group of men will undergo a circumcision using the Shang Ring and men are to return for regular follow-up visits to evaluate pain and wound healing. . The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 60 days. |
| 2 | Active comparator | Procedure: Male circumcisionOne group of men will undergo a conventional circumcision using a WHO recommended surgical technique, either the forceps-guided method or the dorsal slit method. Men are to return for regular follow-up visits to evaluate pain and wound healing, with the last scheduled follow-up visit at 60 days. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must be HIV sero-negative, with documentation of testing no more than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
Key exclusion criteria (5 listed)
- Has a known allergy or sensitivity to lidocaine or other local anesthesia;
- Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- Has known bleeding/clotting disorder (e.g. hemophilia); or
- Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study;
- Is not currently participating in another biomedical study.
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 |
|---|---|---|
| Shang RingThe Shang Ring is a sterile device consisting of 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. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing | Device | 1 |
| Male circumcisionA conventional surgical procedure will be performed, per WHO recommendations, involving: drawing a line to mark the amount of foreskin to be cut; cutting off the foreskin; hemostasis; and wound closure with sutures. | Procedure or surgery | 2 |
Primary outcome
Pain scores on the Visual Analog Scale
Time frame: Within the first 48 hours after circumcision
We will ask participants about pain they experienced during and soon after the procedure, and during the recovery period.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to six weeks after surgery
We will classify circumcision-related adverse events, using the detailed definitions of moderate and severe events per standardized protocol definitions, based on WHO recommendations. Most post-operative complications are apparent within six weeks of surgery.
1 secondary outcome
Compare the cost of the Shang Ring procedure versus conventional surgery
Time frame: Three 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 16 Mar 2012.
- Derived from this study: PubMed 33786810Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions. Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.
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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.
Marc Goldstein, MD principal investigator
Weill Medical College of Cornell University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Shang Ring and Male circumcision in people with Circumcision, Male, run by FHI 360 at 2 sites in 2 countries.
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 10 inclusion and 5 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Zambia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain scores on the Visual Analog Scale (time frame: Within the first 48 hours after circumcision). 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?
On the ClinicalTrials.gov record for NCT01300910, which also lists 1 linked publication.
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 16 Mar 2012.