The Shang Ring: A Novel Male Circumcision Device for HIV Prevention (ShangRing)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00993811 |
Recruitment Status :
Completed
First Posted : October 14, 2009
Last Update Posted : December 6, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Male Circumcision HIV Prevention HIV Infections | Device: Shang Ring circumcision | Phase 1 |

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 |
Arm | Intervention/treatment |
---|---|
Experimental: Circumcision
Males undergoing circumcision
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Device: Shang Ring circumcision
novel device for adult male circumcision
Other Name: adult male circumcision |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 54 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

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
Kenya | |
Homa Bay District Hospital | |
Homa Bay, Kenya |
Study Director: | Mark Barone, DMD | EngenderHealth | |
Principal Investigator: | Marc Goldstein, M.D. | Weill Medical College of Cornell University |
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 |