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

Status Completed

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.

Clinical Trial 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

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

• NCT number: NCT01891409
• Study type: Interventional
• Source: EngenderHealth
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Completion date: November 2013