Pilot Trial of Novel Circumcision Device
|ClinicalTrials.gov Identifier: NCT01885286|
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Safe Circumcision||Procedure: circumcision with simple circumcision device||Not Applicable|
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)|
|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|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||October 2012|
- Procedure: circumcision with simple circumcision device
Circumcision performed with the device in the operating room using local anesthesia
- 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.
- Time of circumcision [ Time Frame: 1 day ]To determine how long the operative procedure required to complete
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|
|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|