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

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.

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Device: PrePex

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Livingstone, Zambia
    • Dambwa North Clinic
  • Lusaka province
    • Lusaka, Lusaka province, Zambia
      • Matero Main Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PrePex Day 0 foreskin removal; Day 0 foreskin removal	Device: PrePex; Prepex is a non surgical male circumcision device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of incidents related to the change in procedure	To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses	8 weeks
Acceptability of the changes procedure to patients	To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal; Patients willingness to wait for foreskin removal; Odour while device is in situ; Pain at key time points on Removal visit; Discomfort of any type to patients.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the change in procedure on circumcision healing time	To assess the circumcision healing time period.	8 weeks

Collaborators and Investigators

• Sponsor: Ministry of Health, Zambia

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2017
• Primary Completion (Actual): April 22, 2017
• Study Completion (Actual): June 17, 2017

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0001 (Cancer Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No