Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya

Human Immunodeficiency Virus Clinical Trial

Official title:

Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891409
• Other study ID #: GCC-0139-01
• Secondary ID: GCC-0139
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: January 15, 2015
• Start date: July 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2015
• Source: EngenderHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeKenya: Ministry of Health
• Study type: Interventional

Clinical 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. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 1 Month to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Device:
• Male circumcision using the Shang Ring device

Locations

Country	Name	City	State
Kenya	Homa Bay District Hospital	Homa Bay

Sponsors (4)

Lead Sponsor	Collaborator
EngenderHealth	Kenya Ministry of Health, Kenya National AIDS & STI Control Programme, Weill Medical College of Cornell University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	42 days after circumcision	Yes
Secondary	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.	42 days after circumcision	Yes
Secondary	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.	42 days after circumcision	Yes
Secondary	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.	42 days after circumcison	No
Secondary	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	42 days after circumcision	No