Pilot Trial of Novel Circumcision Device

Not Applicable

Completed

• Conditions: Safe Circumcision

• Registration Number: NCT01885286
• Lead Sponsor: VA Puget Sound Health Care System

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2013-06
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device	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.

Secondary Outcome Measures

Name	Time	Method
Time of circumcision	1 day	To determine how long the operative procedure required to complete

Trial Locations

Locations (1)

Veterans Administration Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States