Pilot Trial of Novel Circumcision Device
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 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|
- 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.
- Time of circumcision [ Time Frame: 1 day ] [ Designated as safety issue: No ]To determine how long the operative procedure required to complete
|Study Start Date:||September 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Procedure: circumcision with simple circumcision device
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|