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Comparison of the Shang Ring With Conventional Surgical Methods

NCT01300910 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-03-16

No results posted yet for this study

Summary

This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).

Conditions

  • Circumcision, Male

Interventions

DEVICE

Shang Ring

The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing

PROCEDURE

Male circumcision

A conventional surgical procedure will be performed, per WHO recommendations, involving: drawing a line to mark the amount of foreskin to be cut; cutting off the foreskin; hemostasis; and wound closure with sutures.

Sponsors & Collaborators

  • EngenderHealth

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Kenya National AIDS & STI Control Programme

    collaborator OTHER

  • Ministry of Medical Services, Kenya

    collaborator OTHER

  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Marc Goldstein, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Kenya
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01300910 on ClinicalTrials.gov