Status:
COMPLETED
Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Kenya National AIDS & STI Control Programme
Ministry of Medical Services, Kenya
Conditions:
Male Circumcision
Eligibility:
MALE
18-54 years
Phase:
NA
Brief Summary
The objective of this research study is to evaluate the safety and acceptability of the Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a potential rol...
Detailed Description
The objective of this research study is to evaluate the safety and acceptability of the Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device with a potential rol...
Eligibility Criteria
Inclusion
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must be HIV sero-negative, with documentation of testing no mor than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of sexually transmissible infections(STI) on examination;
- Must be able to understand study procedures and requirements of study participation;
- Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;
- Must freely consent to participate in the study and sign a written informed consent form;
- Must have a cell phone or access to a cell phone; and,
- 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 an active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon, prevents the man from undergoing a circumcision;
- Has known bleeding/clotting disorder (e.g. hemophilia); and,
- Has thalassemia (an inherited autosomal recessive blood disease).
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01247844
Start Date
September 1 2010
End Date
January 1 2011
Last Update
March 6 2015
Active Locations (1)
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1
Homa Bay District Hospital
Homa Bay, Nyanza, Kenya, 40300