Unicirc Adolescent 12-15 Year Old Boys

Circumcision, Male Clinical Trial

Official title:

Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593630
• Other study ID #: Unicirc Adolescent
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: November 15, 2016

Study information

• Verified date: January 2019
• Source: Simunye Primary Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Description:

Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 15, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 12 Years to 15 Years

Eligibility

Inclusion Criteria:

• healthy boys desiring circumcision

Exclusion Criteria:

• current illness

• bleeding disorder

• reaction to local anaesthetic

• infection

• any penile abnormality potentially complicating circumcision

Related Conditions & MeSH terms

• Circumcision, Male

Intervention

Device:
• Unicirc circumcision
Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive

Locations

Country	Name	City	State
South Africa	Simunye Primary Healthcare	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
Simunye Primary Health Care

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Duration	Duration from placement of instrument to dressing	Intraoperative, 10-15 minutes
Secondary	Intraoperative Pain	Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.	Time of surgery, approximately 10-15 minutes
Secondary	Healed at 4 Weeks	Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.	At the 4-week followup visit