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Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

NCT02091726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-09-06

Study results available
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Summary

This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.

Conditions

  • Male Circumcision

Interventions

PROCEDURE

Unicirc instrument plus cyanoacrylate tissue adhesive

Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive

Sponsors & Collaborators

  • Simunye Primary Health Care

    lead OTHER

Principal Investigators

  • Norman Goldstuck, MD · Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT02091726 on ClinicalTrials.gov