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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Progressus.
Recruitment status was:  Recruiting
Information provided by:
Progressus Identifier:
First received: December 12, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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 Intervention Phase
Circumcision Male Procedure: Circumcision Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Progressus:

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

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

Estimated Enrollment: 15
Study Start Date: November 2007
Estimated Study Completion Date: March 2008
Intervention Details:
    Procedure: Circumcision
    Circumcision by tying a ligature around the foreskin.

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00572754

Contact: Kasonde Bowa, MD 260 97 84 93 0

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

Responsible Party: Bertran Auvert, University of Versailles (France) Identifier: NCT00572754     History of Changes
Other Study ID Numbers: Drycirc Vz10d
Study First Received: December 12, 2007
Last Updated: December 12, 2007 processed this record on September 21, 2017