Back to resultsUse of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Male circumcision using the Shang Ring device
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring HIV prevention, Male Circumcision, Children, Childhood, Shang Ring
Eligibility 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.
Sites / Locations
- Homa Bay District Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
Single arm study study for use of Shang Ring device for male circumcision in children
Outcomes
Primary Outcome Measures
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
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.
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.
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)
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
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
Full Information
NCT ID
NCT01891409
First Posted
June 25, 2013
Last Updated
January 15, 2015
Sponsor
EngenderHealth
Collaborators
Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT01891409
Brief Title
Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
Official Title
Use of the Shang Ring Device in All Four Childhood Age Groups in the African Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EngenderHealth
Collaborators
Weill Medical College of Cornell University, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV prevention, Male Circumcision, Children, Childhood, Shang Ring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
Single arm study study for use of Shang Ring device for male circumcision in children
Intervention Type
Device
Intervention Name(s)
Male circumcision using the Shang Ring device
Other Intervention Name(s)
Shang ring male circumcision device
Primary Outcome Measure Information:
Title
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Description
Documentation of adverse events based on clinical exam findings
Time Frame
42 days after circumcision
Secondary Outcome Measure Information:
Title
To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Description
To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.
Time Frame
42 days after circumcision
Title
To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Description
Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.
Time Frame
42 days after circumcision
Title
To determine the acceptability of the Shang Ring device by the participants (or their parents)
Description
Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study.
Time Frame
42 days after circumcison
Title
To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents
Description
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
Time Frame
42 days after circumcision
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quentin Awori, MBChB, CPI
Organizational Affiliation
EngenderHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Homa Bay District Hospital
City
Homa Bay
Country
Kenya
12. IPD Sharing Statement
Learn more about this trial
Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
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