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

NCT03132285 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effect of the change in procedure on circumcision healing time

  8 weeks

Study Arms (1)

PrePex Day 0 foreskin removal

OTHER

Day 0 foreskin removal

Device: PrePex

Interventions

PrePex DEVICE

Prepex is a non surgical male circumcision device

PrePex Day 0 foreskin removal

Eligibility Criteria

• Age: 13 Years - 49 Years
• Gender Eligibility Details: Uncircumcised males
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Zambia: lead

Study Sites (2)

Matero Main Clinic

Lusaka, Lusaka Province, Zambia

Location

Dambwa North Clinic

Livingstone, Zambia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgeon

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 27, 2017
• Study Start: March 11, 2017
• Primary Completion: April 22, 2017
• Study Completion: June 17, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)