Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
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ClinicalTrials.gov Identifier: NCT01891409 |
Recruitment Status
:
Completed
First Posted
: July 3, 2013
Last Update Posted
: January 19, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Device: Male circumcision using the Shang Ring device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Single arm
Single arm study study for use of Shang Ring device for male circumcision in children
|
Device: Male circumcision using the Shang Ring device
Other Name: Shang ring male circumcision device
|
- 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
- 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 efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.
- 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 ]Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.
- To determine the acceptability of the Shang Ring device by the participants (or their parents) [ Time Frame: 42 days after circumcison ]Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study.
- 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 ]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

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Ages Eligible for Study: | 1 Month to 17 Years (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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);
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891409
Kenya | |
Homa Bay District Hospital | |
Homa Bay, Kenya |
Principal Investigator: | Quentin Awori, MBChB, CPI | EngenderHealth |
Responsible Party: | EngenderHealth |
ClinicalTrials.gov Identifier: | NCT01891409 History of Changes |
Other Study ID Numbers: |
GCC-0139-01 GCC-0139 ( Other Grant/Funding Number: Grand Challenges Canada ) |
First Posted: | July 3, 2013 Key Record Dates |
Last Update Posted: | January 19, 2015 |
Last Verified: | January 2015 |
Keywords provided by EngenderHealth:
HIV prevention Male Circumcision Children Childhood Shang Ring |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |