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

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ClinicalTrials.gov Identifier: NCT00572754
Recruitment Status : Unknown
Verified December 2007 by Progressus.
Recruitment status was:  Recruiting
First Posted : December 13, 2007
Last Update Posted : December 13, 2007
Sponsor:
Information provided by:
Progressus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Circumcision Male Procedure: Circumcision Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision
Study Start Date : November 2007
Estimated Study Completion Date : March 2008

Intervention Details:
  • Procedure: Circumcision
    Circumcision by tying a ligature around the foreskin.


Primary Outcome Measures :
  1. The operative and short-term post-operative safety rates [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Mobibidity and mortality The length of the residual foreskin. [ Time Frame: 1 month ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572754


Contacts
Contact: Kasonde Bowa, MD 260 97 84 93 0 kbowa@yahoo.com

Locations
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Kasonde Bowa, MD         
Principal Investigator: Kasonde Bowa, MD         
Sponsors and Collaborators
Progressus
Investigators
Principal Investigator: Bertran Auvert, MD, PhD UVSQ-INSERM-France

Responsible Party: Bertran Auvert, University of Versailles (France)
ClinicalTrials.gov Identifier: NCT00572754     History of Changes
Other Study ID Numbers: Drycirc Vz10d
NEB002180
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007