Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placemen… (NCT03132285) | Clinical Trial Compass
CompletedNot Applicable
Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device
Zambia500 participantsStarted 2017-03-11
Plain-language 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.
Who can participate
Age range13 Years – 49 Years
SexMALE
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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
What they're measuring
1
Number of incidents related to the change in procedure
Timeframe: 8 weeks
2
Acceptability of the changes procedure to patients