Pilot Trial of Novel Circumcision Device

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
John Krieger, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT01885286
First received: June 20, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion

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

Exclusion

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885286

Locations
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
Investigators
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:
circumcision
HIV prevention

ClinicalTrials.gov processed this record on July 28, 2014