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Completed

NCT Number: NCT03132285

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

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.

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Key information

Conditions

HIV Prevention

Age range

13 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Matero Main Clinic, Lusaka, Lusaka Province, Zambia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrePex

Device

Prepex is a non surgical male circumcision device

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Effect of the change in procedure on circumcision healing time

    Time frame: 8 weeks

    To assess the circumcision healing time period.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Zambia

Other Gov

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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