Pilot Trial of Novel Circumcision Device

VA Puget Sound Health Care System

Status: Completed

Conditions: Safe Circumcision

Treatments: Procedure: circumcision with simple circumcision device

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01885286

VAPSHCS-00434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

1. Uncircumcised males
2. Aged>18
3. Sexually active
4. No plans for moving in next 6 months
5. Consent to participate

Exclusion

1. History of a bleeding disorder
2. History of a documented concurrent STI of appearance of an STI on initial physical exam
3. Keloid formation or other condition that might unduly increase risk of elective surgery
4. Asprin, anti-coagulants or other clinical contra-indications

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)