NCT01885286

Pilot Trial of Novel Circumcision Device

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: VA Puget Sound Health Care System · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safe Circumcision

Interventions

Type	Name	Description
PROCEDURE	circumcision with simple circumcision device	Circumcision performed with the device in the operating room using local anesthesia

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-10-01
• First posted: 2013-06-24
• Last updated: 2013-06-25

Locations

1 site across 1 country: United States