Safety and Efficacy Study of Non-Surgical MC Device for A... | NCT02581722

Studies
Safety and Efficacy Study of Non-Surgical MC Device for Adolescent Male Population Including Contraindicated Subjects

NCT02581722

Sponsor

Ministry of Health, Rwanda

Status

Unknown status

Last Update Posted

Oct 21, 2015Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Circumcision, Adolescents

Interventions

PrePex Device

Countries

Rwanda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Mar 2016Estimated

First Submitted Date

Oct 19, 2015

First Submission Date that Met QC Criteria

Oct 19, 2015

First Posted Date

Oct 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2015

Last Update Posted Date

Oct 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PrePex Device	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17		up to 7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Glans fully exposed		Up to 7 weeks
The pain at key time points		Up to 7 weeks
Time to complete healing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided