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

June 20, 2013
June 24, 2013
September 2011
June 2012   (final data collection date for primary outcome measure)
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.
Safety 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
Complete list of historical versions of study NCT01885286 on ClinicalTrials.gov Archive Site
Time of circumcision [ Time Frame: 1 day ] [ Designated as safety issue: No ]
To determine how long the operative procedure required to complete
Same as current
Not Provided
Not Provided
 
Pilot Trial of Novel Circumcision Device
Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Safe Circumcision
Procedure: circumcision with simple circumcision device
Circumcision performed with the device in the operating room using local anesthesia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2012
June 2012   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01885286
VAPSHCS-00434
Yes
John Krieger, VA Puget Sound Health Care System
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
VA Puget Sound Health Care System
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP