Observational Study of Male Circumcision Using PrePex Device

CompletedOBSERVATIONAL
Enrollment

427

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
HIV
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.

Trial Locations (1)

Unknown

Nyanza Reproductive Health Society, Kisumu

Sponsors
All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

University of Illinois at Chicago

OTHER

collaborator

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

UNKNOWN

collaborator

Nyanza Reproductive Health Society

OTHER

lead

FHI 360

OTHER