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Observational Study of Male Circumcision Using PrePex Device

NCT01711411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 427

Last updated 2013-11-27

No results posted yet for this study

Summary

The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment. To assure complete ascertainment of AEs, study-specific forms will be used to collect standardized data from the circumcision visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will revert to routine practice (two follow-up visits) for the remaining 375 cases.

Conditions

Interventions

DEVICE

PrePex device for male circumcision

PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Kenyan MOH, Kenyan Natinal AIDS and STI Control Programme(NASCOP)

    collaborator UNKNOWN

  • Nyanza Reproductive Health Society

    collaborator OTHER

  • FHI 360

    lead OTHER

Principal Investigators

  • Paul Feldblum, PhD · FHI 360

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

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 NCT01711411 on ClinicalTrials.gov