Use of Male Circumcision Device in All Four Childhood Groups in the African Population

This study has been completed.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Kenya National AIDS & STI Control Programme
Kenya Ministry of Health
Information provided by (Responsible Party):
EngenderHealth
ClinicalTrials.gov Identifier:
NCT01891409
First received: June 25, 2013
Last updated: February 11, 2014
Last verified: February 2014

June 25, 2013
February 11, 2014
July 2013
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01891409 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Use of Male Circumcision Device in All Four Childhood Groups in the African Population
Use of Male Circumcision Device in All Four Childhood Groups in the African Population

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Human Immunodeficiency Virus
Device: Male circumcision using the Shang Ring device
Other Name: Shang ring male circumcision device
Single arm
Single arm study study for use of Shang Ring device for male circumcision in children
Intervention: Device: Male circumcision using the Shang Ring device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Male
1 Month to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01891409
GCC-0139-01, GCC-0139
Yes
EngenderHealth
EngenderHealth
  • Weill Medical College of Cornell University
  • Kenya National AIDS & STI Control Programme
  • Kenya Ministry of Health
Principal Investigator: Quentin Awori, MBChB, CPI EngenderHealth
EngenderHealth
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP