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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of the PrePex Device for Non-Surgical Adult Male Circumcision During Phased in National Implementation in an Effort to Prevent the Spread of HIV

NCT01921608

Male Circumcision

COMPLETED NA

Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians

NCT02281461

Medical Device Complication

COMPLETED NA

A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

NCT01150370

Male Circumcision HIV Prevention HIV Infections

COMPLETED NA

Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses

NCT01434628

Male Circumcision HIV Prevention

COMPLETED NA

Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting

NCT01284088

HIV

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Circumcision, Adolescents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adolescent male population

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

Group Type EXPERIMENTAL

PrePex Device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PrePex 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes