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

EngenderHealth

Status

Completed

Conditions

Human Immunodeficiency Virus

Treatments

Device: Male circumcision using the Shang Ring device

Study type

Interventional

Funder types

Other

Identifiers

NCT01891409

GCC-0139-01

GCC-0139 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Male

Ages

1 month to 17 years old

Volunteers

Accepts Healthy Volunteers

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.