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Pilot Trial of Novel Circumcision Device

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ClinicalTrials.gov Identifier: NCT01885286
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 25, 2013
University of Washington
Information provided by (Responsible Party):
John Krieger, VA Puget Sound Health Care System

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 surgical circumcision without adverse events.

Condition or disease Intervention/treatment
Safe Circumcision Procedure: circumcision with simple circumcision device

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 pilot trial of a novel surgical device Setting: Tertiary care Veterans Administration medical center Patients: 5 adult males Interventions: Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.

Main Outcome Measure(s): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision
Study Start Date : September 2011
Primary Completion Date : June 2012
Study Completion Date : October 2012

Intervention Details:
    Procedure: circumcision with simple circumcision device
    Circumcision performed with the device in the operating room using local anesthesia

Primary Outcome Measures :
  1. Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device [ Time Frame: 90 days ]
    To determine if the novel surgical device was able to facilitate safe circumcision among adult males. Specifically we looked at: time of surgery, blood loss, ease of use, cosmetic outcome, number of sutures required, need for conversion to another method of circumcision and need for revision surgeries.

Secondary Outcome Measures :
  1. Time of circumcision [ Time Frame: 1 day ]
    To determine how long the operative procedure required to complete

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes


  1. Uncircumcised males
  2. Aged>18
  3. Sexually active
  4. No plans for moving in next 6 months
  5. Consent to participate


  1. History of a bleeding disorder
  2. History of a documented concurrent STI of appearance of an STI on initial physical exam
  3. Keloid formation or other condition that might unduly increase risk of elective surgery
  4. Asprin, anti-coagulants or other clinical contra-indications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885286

United States, Washington
Veterans Administration Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Puget Sound Health Care System
University of Washington
Principal Investigator: John N Krieger, MD University of Washington/Seattle Puget Sound VA Health Care System
Study Director: James M Hotaling, MD MS University of Washington

Responsible Party: John Krieger, Professor of Urology, University of Washington, Section chief Seattle VA urology division, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT01885286     History of Changes
Other Study ID Numbers: VAPSHCS-00434
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by John Krieger, VA Puget Sound Health Care System:
HIV prevention