Pilot Trial of Novel Circumcision Device
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|