Phase 4
N=54
Unicirc Adolescent 12-15 Year Old Boys
Circumcision, Male
Bottom Line
View on ClinicalTrials.gov: NCT02593630 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Intraoperative Duration — 9.5 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Unicirc circumcision (Device)
- Age
- Pediatric · 12+ yrs
- Sex
- Male
- Sponsor
- Simunye Primary Health Care
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Duration |
9.5 | — |
| SECONDARY Intraoperative Pain |
1 | — |
| SECONDARY Healed at 4 Weeks |
53 | — |
Summary
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
Eligibility Criteria
Inclusion Criteria
- healthy boys desiring circumcision
Exclusion Criteria
- current illness
- bleeding disorder
- reaction to local anaesthetic
- infection
- any penile abnormality potentially complicating circumcision
Data sourced from ClinicalTrials.gov (NCT02593630). 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.