Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya - Full Text View

Purpose

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.

Condition	Intervention
Human Immunodeficiency Virus	Device: Male circumcision using the Shang Ring device


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by EngenderHealth:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Documentation of adverse events based on clinical exam findings

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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


Enrollment:	80
Study Start Date:	July 2013
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single arm 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

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.

Eligibility


Ages Eligible for Study:	1 Month to 17 Years (Child)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891409

Locations


Kenya
Homa Bay District Hospital
Homa Bay, Kenya

Sponsors and Collaborators

EngenderHealth

Weill Medical College of Cornell University

Kenya National AIDS & STI Control Programme

Kenya Ministry of Health

Investigators


Principal Investigator:	Quentin Awori, MBChB, CPI	EngenderHealth

More Information


Responsible Party:	EngenderHealth
ClinicalTrials.gov Identifier:	NCT01891409 History of Changes
Other Study ID Numbers:	GCC-0139-01 GCC-0139
Study First Received:	June 25, 2013
Last Updated:	January 15, 2015
Health Authority:	Kenya: Ethical Review Committee Kenya: Ministry of Health

Keywords provided by EngenderHealth:


HIV prevention Male Circumcision Children Childhood Shang Ring

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections	RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2016