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Rapid, Minimally-invasive Voluntary Adult Male Circumcision

NCT01998360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-10-02

Study results available
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Summary

This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.

Conditions

  • Circumcision

Interventions

PROCEDURE

Surgical Control

The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.

PROCEDURE

Unicirc with tissue adhesive

Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Sponsors & Collaborators

  • Simunye Primary Health Care

    lead OTHER

Principal Investigators

  • Norman Goldstuck, MB ChB · Simunye Primary Health Care

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • South Africa

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 NCT01998360 on ClinicalTrials.gov