Status:
COMPLETED
Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
Lead Sponsor:
EngenderHealth
Collaborating Sponsors:
Weill Medical College of Cornell University
Kenya National AIDS & STI Control Programme
Conditions:
Human Immunodeficiency Virus
Eligibility:
MALE
1-17 years
Phase:
NA
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 a...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01891409
Start Date
July 1 2013
End Date
November 1 2013
Last Update
January 19 2015
Active Locations (1)
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1
Homa Bay District Hospital
Homa Bay, Kenya