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Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia

NCT01844102 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2014-05-13

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 among 500 men, 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 transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.

Conditions

Interventions

DEVICE

PrePex

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

  • Population Services International

    collaborator OTHER

  • Population Council

    collaborator OTHER

  • Society for Family Health, Zambia

    collaborator UNKNOWN

  • Ministry of Health, Zambia

    collaborator OTHER_GOV

  • FHI 360

    lead OTHER

Principal Investigators

  • Karin Hatzold, MD, Ph.D. · Population Services International

  • Paul Hewett, Ph.D. · Population Council

  • Namwinga Chintu, MBChB · Society for Family Health

  • Bruce Bvulani, MBChB, MMed · Ministry of Health, Zambia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Zambia

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 NCT01844102 on ClinicalTrials.gov