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

NCT00572754 | Unknown Phase 2 DMC

• 2 other identifiers: Drycirc Vz10dNEB002180
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Circumcision; Male

Outcome Measures

Primary Outcomes (1)

• The operative and short-term post-operative safety rates

  1 month

Secondary Outcomes (1)

• Mobibidity and mortality The length of the residual foreskin.

  1 month

Interventions

Circumcision PROCEDURE

Circumcision by tying a ligature around the foreskin.

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects, aged 21 years or above at the point of screening for participation.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• 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.
• Subjects willing to be circumcised for cultural reasons.
• Subjects living in the site's area.
• Subjects who can be easily contacted by telephone.
• Subjects who can correctly speak and correctly read English.

You may not qualify if:

• Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin).
• Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects who have participated in a clinical study with an investigational product in the last 6 months.
• Subjects who have an abnormal penile anatomy.
• Subjects who are currently involved in any injury litigation claims.
• Subjects who have penile diseases or lesions.
• Subjects who have clinical symptoms of sexually transmitted infections.
• Subjects with opportunistic infections.
• Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation.
• Subjects whose penile circumference is higher (\>3mm) or lower (\<3mm) than the available circumcision tubes.
• Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans \> 5mm).

Sponsors & Collaborators

• Progressus: lead

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

RECRUITING

MeSH Terms

Interventions

Circumcision, Male

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Bertran Auvert, MD, PhD

  UVSQ-INSERM-France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasonde Bowa, MD

CONTACT

260 97 84 93 0; kbowa@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: November 1, 2007
• Study Completion: March 1, 2008
• Last Updated: December 13, 2007

Record last verified: 2007-12

Locations

ZA (1)