NCT01891409

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: EngenderHealth · Academic / Other
• Sex: Male
• Age: 1 Month – 17 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Male circumcision using the Shang Ring device

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-07-03
• Last updated: 2015-01-19

Locations

1 site across 1 country: Kenya