Pilot Trial of Novel Circumcision Device

V

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems