NCT03132285

Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device

Safety and Acceptability Study of Non-Surgical Male Circumcision Device for Adult Male Population When Removing the Foreskin Shortly After Placement of Device Performed at Lusaka and Livingstone, Zambia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Ministry of Health, Zambia · Other Government
• Sex: Male
• Age: 13 Years – 49 Years
• Healthy volunteers: Accepted

Summary

To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

Detailed description

To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement. Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex. Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DEVICE	PrePex	Prepex is a non surgical male circumcision device

Timeline

• Start date: 2017-03-11
• Primary completion: 2017-04-22
• Completion: 2017-06-17
• First posted: 2017-04-27
• Last updated: 2017-09-07

Locations

2 sites across 1 country: Zambia