NCT02581722

Brief Summary

A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

October 19, 2015

Last Update Submit

October 19, 2015

Conditions

Circumcision, Adolescents

Keywords

PrePex, Male Circumcision, HIV Prevention, Adolescents

Outcome Measures

Primary Outcomes (1)

  • Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17

    up to 7 weeks

Secondary Outcomes (5)

  • Glans fully exposed

    Up to 7 weeks

  • The pain at key time points

    Up to 7 weeks

  • Time to complete healing

    Up to 7 weeks

  • Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only

    Up to 7 weeks

  • Rate of side effects

    Up to 7 weeks

Study Arms (1)

Adolescent male population

EXPERIMENTAL

Male circumcision using the PrePex device among healthy adolescent males and contraindicated subjects due to Preputial adhesions and /or narrow foreskin/Phimosis

Device: PrePex Device

Interventions

PrePex DeviceDEVICE

The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.

Adolescent male population

Eligibility Criteria

Age10 Years - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent Males in ages - 10 to 17 years
  • Uncircumcised
  • Subject wants to be circumcised
  • Subject assent to the procedure
  • Legal guardian consent to the procedure
  • Subject with or without the following conditions: Preputial adhesions and /or narrow foreskin/Phimosis
  • 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)
  • Subject 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
  • Subject agrees to anonymous video and photographs of the procedure and follow up visits.

You may not qualify if:

  • Legal guardian withholds consent
  • Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
  • Subject with the following diseases/conditions: paraphimosis, warts under the prepuce, torn or tight frenulum, hypospadias, epispadias
  • Known bleeding / coagulation abnormality, uncontrolled diabetes
  • Subject that to the opinion of the investigator is not a good candidate
  • Subject does not agree to anonymous video and photographs of the procedure and follow up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rwanda Military Hospital

Kigali, Kigali, 3377, Rwanda

Location

Related Links

Study Officials

  • Vincent Mutabazi, M.D.

    Ministry of Health, Rwanda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Research Grants Unit

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 21, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

RW(1)