Status:

COMPLETED

Pilot Trial of Novel Circumcision Device

Lead Sponsor:

VA Puget Sound Health Care System

Collaborating Sponsors:

University of Washington

Conditions:

Safe Circumcision

Eligibility:

MALE

18+ years

Phase:

NA

Brief Summary

The investigators are testing a novel surgical device to facilitate safe circumcision among adult males. The investigators hypothesize that this device will allow non-medical providers to perform safe...

Detailed Description

Objective: To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision. Design: Prospective pi...

Eligibility Criteria

Inclusion

  • Inclusion
  • Uncircumcised males
  • Aged\>18
  • Sexually active
  • No plans for moving in next 6 months
  • Consent to participate
  • Exclusion
  • History of a bleeding disorder
  • History of a documented concurrent STI of appearance of an STI on initial physical exam
  • Keloid formation or other condition that might unduly increase risk of elective surgery
  • Asprin, anti-coagulants or other clinical contra-indications

Exclusion

    Key Trial Info

    Start Date :

    September 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2012

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT01885286

    Start Date

    September 1 2011

    End Date

    October 1 2012

    Last Update

    June 25 2013

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Veterans Administration Puget Sound Health Care System

    Seattle, Washington, United States, 98108