NCT01998360

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 15, 2014

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

Same day

First QC Date

October 11, 2013

Results QC Date

November 27, 2013

Last Update Submit

September 4, 2018

Conditions

Circumcision

Keywords

CircumcisionVoluntary medical male circumcisionMinimally-invasiveHIV prevention

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Duration

    The number of minutes required to perform the surgical procedure

    1 hour

Secondary Outcomes (4)

  • Number of Participants With Adverse Events

    1 month

  • Blood Loss

    During procedure (up to 1 hour)

  • Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks

    1 month

  • Cosmetic Result

    6 weeks

Study Arms (2)

Unicirc with tissue adhesive

EXPERIMENTAL

Excision of foreskin with Unicirc device and sealing wound with tissue adhesive

Procedure: Unicirc with tissue adhesive

Surgical control

ACTIVE COMPARATOR

Surgical circumcision using forceps guided, dorsal slit, or sleeve method

Procedure: Surgical Control

Interventions

Surgical ControlPROCEDURE

The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.

Surgical control
Unicirc with tissue adhesivePROCEDURE

Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Unicirc with tissue adhesive

Eligibility Criteria

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

You may qualify if:

  • 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 -

You may not qualify if:

  • Current illness
  • Penile abnormality or infection which contraindicates or would complicate circumcision
  • History of bleeding disorder
  • Past reaction to local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simunye Primary Healthcare

Mitchells Plain, Western Cape, South Africa

Location

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesSurgical Fixation DevicesSurgical EquipmentEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Peter S. Millard, MD, PhD
Organization
University of New England
pmillard@mac.com
2078663503

Study Officials

  • Norman Goldstuck, MB ChB

    Simunye Primary Health Care

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 11, 2013

First Posted

November 28, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 2, 2018

Results First Posted

January 15, 2014

Record last verified: 2018-09

Locations

ZA(1)