Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01891409|
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : January 19, 2015
|Condition or disease||Intervention/treatment|
|Human Immunodeficiency Virus||Device: Male circumcision using the Shang Ring device|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population|
|Study Start Date :||July 2013|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Single arm study study for use of Shang Ring device for male circumcision in children
Device: Male circumcision using the Shang Ring device
Other Name: Shang ring male circumcision device
- To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. [ Time Frame: 42 days after circumcision ]Documentation of adverse events based on clinical exam findings
- To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. [ Time Frame: 42 days after circumcision ]To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.
- To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. [ Time Frame: 42 days after circumcision ]Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.
- To determine the acceptability of the Shang Ring device by the participants (or their parents) [ Time Frame: 42 days after circumcison ]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 technique across the 4 age groups ranging from infants to adolescents [ Time Frame: 42 days after circumcision ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891409
|Homa Bay District Hospital|
|Homa Bay, Kenya|
|Principal Investigator:||Quentin Awori, MBChB, CPI||EngenderHealth|