N/A
N=100
Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Circumcision
Bottom Line
View on ClinicalTrials.gov: NCT01998360 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Intraoperative Duration — 9.0; 22.6 Min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgical Control (Procedure); Unicirc with tissue adhesive (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Simunye Primary Health Care
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Duration |
9.0; 22.6 | — |
| SECONDARY Number of Participants With Adverse Events |
4; 9 | — |
| SECONDARY Blood Loss |
1.5; 5.5 | — |
| SECONDARY Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks |
49; 49 | — |
| SECONDARY Cosmetic Result |
50; 20; 0; 8; 0; 22 | — |
Summary
This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Eligibility Criteria
Inclusion Criteria
Healthy men at least 18 years of age requesting circumcision
No anatomical penile abnormalities or infections
Able to provide informed consent to participate
Willing to participate in follow-up visits -
Exclusion Criteria
Current illness
Penile abnormality or infection which contraindicates or would complicate circumcision
History of bleeding disorder
Past reaction to local anesthetic
-
Data sourced from ClinicalTrials.gov (NCT01998360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.