Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method

Study Overview
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Brief Summary
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The objective of this clinical investigation is to provide the first and preliminary clinical data to study the safety and efficacy of male circumcision where the dry circumcision method is employed.

Official Title
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Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision

Conditions
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Circumcision, Male

Intervention / Treatment
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* Procedure: Circumcision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects, aged 21 years or above at the point of screening for participation. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. Subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation co-operate with the investigational procedures and are willing to return to the clinical centre for all the required post-treatment follow-ups. Subjects willing to be circumcised for cultural reasons. Subjects living in the site's area. Subjects who can be easily contacted by telephone. Subjects who can correctly speak and correctly read English. Exclusion Criteria: Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin). Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. Subjects who have participated in a clinical study with an investigational product in the last 6 months. Subjects who have an abnormal penile anatomy. Subjects who are currently involved in any injury litigation claims. Subjects who have penile diseases or lesions. Subjects who have clinical symptoms of sexually transmitted infections. Subjects with opportunistic infections. Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation. Subjects whose penile circumference is higher (>3mm) or lower (<3mm) than the available circumcision tubes. Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans > 5mm).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Circumcision|Circumcision by tying a ligature around the foreskin.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The operative and short-term post-operative safety rates |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobibidity and mortality The length of the residual foreskin. |  | 1 month |