Veterans Administration Puget Sound Health Care System
Seattle, Washington, 98108, United States
Completed
NCT Number: NCT01885286
Pilot Trial of Novel Circumcision Device
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
circumcision with simple circumcision device
ProcedureCircumcision performed with the device in the operating room using local anesthesia
Primary outcomes
-
Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device
Time frame: 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 outcomes
-
Time of circumcision
Time frame: 1 day
To determine how long the operative procedure required to complete
Sponsors and collaborators
Lead sponsor
VA Puget Sound Health Care System
Fed
Collaborators
- University of Washington
Registry information
Official study title
Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jun 24, 2013
- Registry last updated
- Jun 25, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.