Pilot Trial of Novel Circumcision Device

June 24, 2013 updated by: John Krieger, VA Puget Sound Health Care System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Administration Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of circumcision
Time Frame: 1 day
To determine how long the operative procedure required to complete
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Puget Sound Health Care System

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VAPSHCS-00434

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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