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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03132285
Other study ID # 0001
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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