Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device
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|ClinicalTrials.gov Identifier: NCT03132285|
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Prevention||Device: PrePex||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 11, 2017|
|Actual Primary Completion Date :||April 22, 2017|
|Actual Study Completion Date :||June 17, 2017|
PrePex Day 0 foreskin removal
Day 0 foreskin removal
Prepex is a non surgical male circumcision device
- Number of incidents related to the change in procedure [ Time Frame: 8 weeks ]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
- Acceptability of the changes procedure to patients [ Time Frame: 8 weeks ]
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.
- Effect of the change in procedure on circumcision healing time [ Time Frame: 8 weeks ]To assess the circumcision healing time period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132285
|Matero Main Clinic|
|Lusaka, Lusaka province, Zambia|
|Dambwa North Clinic|