NCT02593630

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 4, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

October 29, 2015

Results QC Date

April 7, 2017

Last Update Submit

January 31, 2019

Conditions

Circumcision, Male

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Duration

    Duration from placement of instrument to dressing

    Intraoperative, 10-15 minutes

Secondary Outcomes (2)

  • Intraoperative Pain

    Time of surgery, approximately 10-15 minutes

  • Healed at 4 Weeks

    At the 4-week followup visit

Study Arms (1)

Unicirc circumcision

EXPERIMENTAL

Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive

Device: Unicirc circumcision

Interventions

Unicirc circumcisionDEVICE

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

Unicirc circumcision

Eligibility Criteria

Age12 Years - 15 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy boys desiring circumcision

You may not qualify if:

  • current illness
  • bleeding disorder
  • reaction to local anaesthetic
  • infection
  • any penile abnormality potentially complicating circumcision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simunye Primary Healthcare

Cape Town, Western Cape, South Africa

Location

Related 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.

    PMID: 25822727BACKGROUND

Limitations and Caveats

There were no limitations, other than the fact that this study was not a comparison study but a cohort interventional study. Followup was not totally complete but very nearly so.

Results Point of Contact

Title
Peter S. Millard, MD, Phd
Organization
University of New England
pmillard@mac.com
2072992131

Study Officials

  • Norman Goldstuck

    University of Stellenbosch

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 2, 2015

Study Start

April 1, 2016

Primary Completion

November 15, 2016

Study Completion

November 15, 2016

Last Updated

February 4, 2019

Results First Posted

February 4, 2019

Record last verified: 2019-01

Locations

ZA(1)