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

NCT ID: NCT03132285

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-11
• Study Completion Date: 2017-06-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PrePex Day 0 foreskin removal

Day 0 foreskin removal

Group Type: OTHER

PrePex

Intervention Type: DEVICE

Prepex is a non surgical male circumcision device

Interventions

PrePex

Prepex is a non surgical male circumcision device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ages - 13 to 49 years
• Uncircumcised
• Participant wants to be circumcised
• Participant assent to the procedure
• Legal guardian consent to the procedure for ages 13-18 years
• Able to understand the study procedures and requirements
• Agrees to abstain from sexual intercourse for 8 weeks after circumcision
• Agrees to abstain from masturbation for at least 2 weeks after Removal
• Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
• Participant able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion Criteria

• Legal guardian withholds consent for ages 13-18 years
• Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
• Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
• Known bleeding / coagulation abnormality, uncontrolled diabetes
• Participant that to the opinion of the investigator is not a good candidate
• Diabetes Mellitus
• HIV Sero-positive

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role: lead

Responsible Party

David Linyama

General surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Matero Main Clinic

Lusaka, Lusaka Province, Zambia

Dambwa North Clinic

Livingstone, , Zambia

Countries

Zambia

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id