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

PHASE4CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
HIV
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.

Trial Locations (1)

Unknown

Society for Family Health, Lusaka

Sponsors
All Listed Sponsors
collaborator

Population Services International

OTHER

collaborator

Population Council

OTHER

collaborator

Society for Family Health, Zambia

UNKNOWN

collaborator

Ministry of Health, Zambia

OTHER_GOV

lead

FHI 360

OTHER

NCT01844102 - Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia | Biotech Hunter | Biotech Hunter