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

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132285
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: September 6, 2017
• Start date: March 11, 2017
• Est. completion date: June 17, 2017

Study information

• Verified date: September 2017
• Source: Ministry of Health, Zambia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 17, 2017
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Device:
• PrePex
Prepex is a non surgical male circumcision device

Locations

Country	Name	City	State
Zambia	Dambwa North Clinic	Livingstone
Zambia	Matero Main Clinic	Lusaka	Lusaka province

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Effect of the change in procedure on circumcision healing time	To assess the circumcision healing time period.	8 weeks