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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 because the information has not been verified recently.
Verified December 2007 by Progressus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Progressus
ClinicalTrials.gov Identifier:
NCT00572754
First received: December 12, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision

Resource links provided by NLM:

MedlinePlus related topics: Circumcision
U.S. FDA Resources

Further study details as provided by Progressus:

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

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

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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Bertran Auvert, University of Versailles (France)
ClinicalTrials.gov Identifier: NCT00572754     History of Changes
Other Study ID Numbers: Drycirc Vz10d, NEB002180
Study First Received: December 12, 2007
Last Updated: December 12, 2007
Health Authority: France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on May 21, 2013