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The Shang Ring: A Novel Male Circumcision Device for HIV Prevention (ShangRing)

This study has been completed.
Sponsor:
Collaborator:
EngenderHealth
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00993811
First received: October 9, 2009
Last updated: December 3, 2010
Last verified: October 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary medical male circumcision, in order to improve the provision of male circumcision services for HIV prevention in Africa.


Condition Intervention Phase
Male Circumcision
HIV Prevention
HIV Infections
 Device: Shang Ring circumcision
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Shang Ring: A Novel Male Circumcision Device for HIV Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The efficacy and safety of the ShangRIng device for adult male circumcision in an HIV endemic region in Africa. [ Time Frame: Six week post-operative follow up appointment and examination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Behavior outcomes (surgical acceptability, satisfaction, problems encountered with the device, compliance with post-surgical instructions, and correct knowledge about the extent of the protective effect of circumcision and safe sex). [ Time Frame: Six week post-operative follow up appointment and examination ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Circumcision
Males undergoing circumcision
 Device: Shang Ring circumcision
novel device for adult male circumcision
Other Name: adult male circumcision

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Freely consents to participate in the study and signs an informed consent form
  • Ages 18 - 54 years
  • Uncircumcised
  • Good general health
  • HIV sero-negative
  • Able to understand the study procedures and requirements
  • Agrees to return to the health care facility for the full schedule of follow-up visits after his circumcision

Exclusion Criteria:

  • Previous circumcision on examination
  • Age < 18 years or > 54 years
  • Active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon prevents the man from undergoing a circumcision
  • HIV sero-positive
  • A condition, which in the opinion of the surgeon contradicts participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993811

Locations
Kenya
Homa Bay District Hospital
Homa Bay, Kenya
Sponsors and Collaborators
Weill Medical College of Cornell University
EngenderHealth
Investigators
Study Director: Mark Barone, DMD EngenderHealth
Principal Investigator: Marc Goldstein, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Marc Goldstein, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00993811     History of Changes
Other Study ID Numbers: 0902010241
Study First Received: October 9, 2009
Last Updated: December 3, 2010
Health Authority: Kenya: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
male circumcision
HIV
Africa
HIV Seronegativity

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

ClinicalTrials.gov processed this record on March 14, 2013