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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Linyama, Ministry of Health, Zambia
ClinicalTrials.gov Identifier:
NCT03132285
First received: April 4, 2017
Last updated: May 11, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
HIV Prevention
Device: PrePex

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
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

Further study details as provided by David Linyama, Ministry of Health, Zambia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Effect of the change in procedure on circumcision healing time [ Time Frame: 8 weeks ]
    To assess the circumcision healing time period.


Enrollment: 500
Actual Study Start Date: March 11, 2017
Estimated Study Completion Date: May 17, 2017
Primary Completion Date: April 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PrePex Day 0 foreskin removal
Day 0 foreskin removal
Device: PrePex
Prepex is a non surgical male circumcision device

Detailed 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.

  Eligibility

Ages Eligible for Study:   13 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Un-Circumstanced males
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03132285

Locations
Zambia
Matero Main Clinic
Lusaka, Lusaka province, Zambia
Dambwa North Clinic
Livingstone, Zambia
Sponsors and Collaborators
Ministry of Health, Zambia
  More Information

Responsible Party: David Linyama, General surgeon, Ministry of Health, Zambia
ClinicalTrials.gov Identifier: NCT03132285     History of Changes
Other Study ID Numbers: 0001
Study First Received: April 4, 2017
Last Updated: May 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on May 25, 2017