Protocol No: ECCT/13/05/01 Date of Protocol: 05-02-2013

Study Title:

Use of the Shang Ring device in all four childhood age groups in the African population

Study Objectives:
Laymans Summary:
Abstract of Study:

 

Primary Objectives

The primary objective of this research study is:

  • To evaluate the safety, efficacy and the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.

 

Secondary Objectives

The secondary objectives of this research study are:

  • To determine the acceptability of the Shang Ring device by the participants(or their parents)

 

  • To evaluate the ease of use of using the Shang Ring as a device for male circumcision across four age groups.

 

Primary Endpoints

We will address the primary objectives by evaluating the following endpoints:

  • To evaluate efficacy, procedural time and peri- and postoperative surgical complications associated with pediatric Shang Ring circumcision shall be assessed. To evaluate safety, we will clinically observe for adverse events during the course of healing. We will also evaluate the length of time required for complete healing.

Secondary Endpoints

We will address the secondary objectives by evaluating the following endpoints:

  • To determine client acceptability, the clients (and/or parents) shall be interviewed on their experience with the Shang Ring during their participation in the study.

 

  • 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, and answer a final questionnaire on their recommendation