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

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ClinicalTrials.gov Identifier: NCT00993811
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : December 6, 2010
Sponsor:
Collaborator:
EngenderHealth
Information provided by:
Weill Medical College of Cornell University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Male Circumcision HIV Prevention HIV Infections Device: Shang Ring circumcision Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Shang Ring: A Novel Male Circumcision Device for HIV Prevention
Study Start Date : October 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Circumcision
Males undergoing circumcision
 Device: Shang Ring circumcision
novel device for adult male circumcision
Other Name: adult male circumcision


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Marc Goldstein, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00993811     History of Changes
Other Study ID Numbers: 0902010241
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: October 2009

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

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