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

December 12, 2007
December 12, 2007
November 2007
Not Provided
The operative and short-term post-operative safety rates [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Mobibidity and mortality The length of the residual foreskin. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Circumcision
  • Male
Procedure: Circumcision
Circumcision by tying a ligature around the foreskin.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
March 2008
Not Provided

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).
Male
21 Years and older
Yes
Contact: Kasonde Bowa, MD 260 97 84 93 0 kbowa@yahoo.com
Zambia
 
NCT00572754
Drycirc Vz10d, NEB002180
Yes
Bertran Auvert, University of Versailles (France)
Progressus
Not Provided
Principal Investigator: Bertran Auvert, MD, PhD UVSQ-INSERM-France
Progressus
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP