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

NCT ID: NCT01891409

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-11-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single arm

Single arm study study for use of Shang Ring device for male circumcision in children

Group Type: OTHER

Male circumcision using the Shang Ring device

Intervention Type: DEVICE

Interventions

Male circumcision using the Shang Ring device

Intervention Type: DEVICE

Other Intervention Names

Shang ring male circumcision device

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Kenya National AIDS & STI Control Programme

OTHER

Sponsor Role: collaborator

Kenya Ministry of Health

OTHER_GOV

Sponsor Role: collaborator

EngenderHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quentin Awori, MBChB, CPI

Role: PRINCIPAL_INVESTIGATOR

EngenderHealth

Locations

Homa Bay District Hospital

Homa Bay, , Kenya

Countries

Kenya

Other Identifiers

GCC-0139

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GCC-0139-01

Identifier Type: -

Identifier Source: org_study_id