Pilot Trial of Novel Circumcision Device

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision

Conditions
-----------------
Safe Circumcision

Intervention / Treatment
-----------------
* Procedure: circumcision with simple circumcision device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Uncircumcised males Aged>18 Sexually active No plans for moving in next 6 months Consent to participate Exclusion History of a bleeding disorder History of a documented concurrent STI of appearance of an STI on initial physical exam Keloid formation or other condition that might unduly increase risk of elective surgery Asprin, anti-coagulants or other clinical contra-indications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: circumcision with simple circumcision device|Circumcision performed with the device in the operating room using local anesthesia|

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 | 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 | To determine how long the operative procedure required to complete | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circumcision, HIV prevention