Clinical trial NCT00572754: Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method
Official title: Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Circumcision
Male
Lead sponsor: Progressus
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: The operative and short-term post-operative safety rates
timeFrame: 1 month
Secondary outcomes:
measure: Mobibidity and mortality The length of the residual foreskin.
timeFrame: 1 month
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: UVSQ-INSERM-France
name: Bertran Auvert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: