Pilot Trial of Novel Circumcision Device

This study has been completed.
University of Washington
Information provided by (Responsible Party):
John Krieger, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
First received: June 20, 2013
Last updated: June 24, 2013
Last verified: June 2013

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 Intervention
Safe Circumcision
Procedure: circumcision with simple circumcision device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by VA Puget Sound Health Care System:

Primary Outcome Measures:
  • Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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:
  • Time of circumcision [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    To determine how long the operative procedure required to complete

Enrollment: 5
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: circumcision with simple circumcision device
    Circumcision performed with the device in the operating room using local anesthesia
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.


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 20, 2013
Last Updated: June 24, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014