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

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

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.

Study Overview

• Status: Unknown
• Conditions: Male; Circumcision
• Intervention / Treatment: Procedure: Circumcision

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Recruiting
    • University Teaching Hospital
    • Contact: Kasonde Bowa, MD
    • Principal Investigator: Kasonde Bowa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male subjects, aged 21 years or above at the point of screening for participation.
2. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
3. 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.
4. Subjects willing to be circumcised for cultural reasons.
5. Subjects living in the site's area.
6. Subjects who can be easily contacted by telephone.
7. Subjects who can correctly speak and correctly read English.

Exclusion Criteria:

1. Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
2. Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin).
3. Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum.
4. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
5. Subjects who have participated in a clinical study with an investigational product in the last 6 months.
6. Subjects who have an abnormal penile anatomy.
7. Subjects who are currently involved in any injury litigation claims.
8. Subjects who have penile diseases or lesions.
9. Subjects who have clinical symptoms of sexually transmitted infections.
10. Subjects with opportunistic infections.
11. Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation.
12. Subjects whose penile circumference is higher (>3mm) or lower (<3mm) than the available circumcision tubes.
13. Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans > 5mm).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Progressus
• Investigators: Principal Investigator: Bertran Auvert, MD, PhD, UVSQ-INSERM-France

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Study Completion (Anticipated): March 1, 2008

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 12, 2007
• First Posted (Estimate): December 13, 2007

Study Record Updates

• Last Update Posted (Estimate): December 13, 2007
• Last Update Submitted That Met QC Criteria: December 12, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: Drycirc Vz10d; NEB002180