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

NCT ID: NCT00572754

Last Updated: 2007-12-13

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-03-31

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.

Detailed Description

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Conditions

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Circumcision Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Circumcision

Circumcision by tying a ligature around the foreskin.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Progressus

OTHER

Sponsor Role lead

Responsible Party

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University of Versailles (France)

Principal Investigators

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Bertran Auvert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UVSQ-INSERM-France

Locations

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University Teaching Hospital

Lusaka, , Zambia

Site Status RECRUITING

Countries

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Zambia

Central Contacts

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Kasonde Bowa, MD

Role: CONTACT

Phone: 260 97 84 93 0

Email: [email protected]

Facility Contacts

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Kasonde Bowa, MD

Role: primary

Other Identifiers

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NEB002180

Identifier Type: -

Identifier Source: secondary_id

Drycirc Vz10d

Identifier Type: -

Identifier Source: org_study_id