NCT02091726

Brief Summary

This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

March 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

December 11, 2014

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

March 14, 2014

Results QC Date

December 1, 2014

Last Update Submit

September 4, 2018

Conditions

Male Circumcision

Keywords

CircumcisionHIV preventionSurgical deviceCyanoacrylateTissue Adhesivevoluntary

Outcome Measures

Primary Outcomes (1)

  • Time for Procedure

    Intraoperative time, total

    1 hour

Secondary Outcomes (4)

  • Completely Healed at 4 Weeks

    4 weeks

  • Wound Separation

    4 weeks

  • Cosmetic Result Excellent

    4 weeks

  • Participant Fully Satisfied and Would Recommend to Friends and Family

    4 weeks

Study Arms (1)

Unicirc with tissue adhesive

EXPERIMENTAL

Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate

Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive

Interventions

Unicirc instrument plus cyanoacrylate tissue adhesivePROCEDURE

Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive

Also known as: Unicirc, Cyanoacrylate
Unicirc with tissue adhesive

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men at least 18 years of age

You may not qualify if:

  • Poor general health
  • Anatomical abnormalities that would complicate circumcision
  • Bleeding disorder
  • Ongoing infection
  • Cannot attend followup visits

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: 25822727DERIVED

MeSH Terms

Interventions

Cyanoacrylates

Intervention Hierarchy (Ancestors)

AcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

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

Study Officials

  • Norman Goldstuck, MD

    Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
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

March 14, 2014

First Posted

March 19, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 6, 2018

Results First Posted

December 11, 2014

Record last verified: 2018-09

Locations

ZA(1)