Human Immunodeficiency VirusNCT01891409
Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
A study testing Male circumcision using the Shang Ring device in people with Human Immunodeficiency Virus, run by EngenderHealth at 1 site in Kenya.
Trial summary
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. Read more about this study
- Who is it for?
- Ages 1 month to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Male circumcision using the Shang Ring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2013to Nov 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 1 month to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents for participation of the child into the study;
- Assent from participant 7 years of age and above who understand study procedure;
- Aged between 1 month and 17 years(inclusive);
- Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.
- Must be in good general health;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
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- Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
- Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
- Parent or LAR must have a cell phone or access to a cell phone; and,
- Parent or LAR 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);
- Has any congenital genitourinary abnormality;
- 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; or
- Is currently participating in another biomedical research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.
Read the detailed description
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Male circumcision using the Shang Ring device
- Keywords
- HIV prevention, Male Circumcision, Children, Childhood, Shang Ring
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male circumcision using the Shang Ring deviceDevice
Also called Shang ring male circumcision device
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm study study for use of Shang Ring device for male circumcision in children Receives: Device: Male circumcision using the Shang Ring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Documentation of adverse events based on clinical exam findings
Measured: 42 days after circumcision
Secondary outcomes (4)
To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.
Measured: 42 days after circumcision
To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.
Measured: 42 days after circumcision
To determine the acceptability of the Shang Ring device by the participants (or their parents)
Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study.
Measured: 42 days after circumcison
To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents
To evaluate the ease of use of the Shang Ring device, clinicians shall be interviewed on the difficulties they faced with using the device and their perception about use of the device relative to conventional surgical approaches
Measured: 42 days after circumcision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- EngenderHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Quentin Awori, MBChB, CPI, Principal investigator, EngenderHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891409
- Sponsor's protocol ID
- GCC-0139-01
- Other IDs
- GCC-0139
- Status last verified
- Jan 2015
- First submitted
- 25 Jun 2013
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population
- ClinicalTrials.gov ID
- NCT01891409
- Acronym / sponsor ID
- GCC-0139-01
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV prevention, Male Circumcision, Children, Childhood, Shang Ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- EngenderHealthUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Jul 2013 (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.
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.
Detailed description
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Male circumcision using the Shang Ring deviceSingle arm study study for use of Shang Ring device for male circumcision in children |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents for participation of the child into the study;
- Assent from participant 7 years of age and above who understand study procedure;
- Aged between 1 month and 17 years(inclusive);
- Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.
- Must be in good general health;
Key exclusion criteria (6 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);
- Has any congenital genitourinary abnormality;
- 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; or
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 |
|---|---|---|
| Male circumcision using the Shang Ring deviceAlso: Shang ring male circumcision device | Device | Single arm |
Primary outcome
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Time frame: 42 days after circumcision
Documentation of adverse events based on clinical exam findings
4 secondary outcomes
To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Time frame: 42 days after circumcision
To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Time frame: 42 days after circumcision
To determine the acceptability of the Shang Ring device by the participants (or their parents)
Time frame: 42 days after circumcison
To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents
Time frame: 42 days after circumcision
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 19 Jan 2015.
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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.
Quentin Awori, MBChB, CPI principal investigator
EngenderHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Male circumcision using the Shang Ring device in people with Human Immunodeficiency Virus, run by EngenderHealth at 1 site in Kenya.
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 6 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 19 Jan 2015. 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 Kenya. 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?
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. (time frame: 42 days after circumcision). 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 19 Jan 2015.