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| Sponsored by: |
Engineers & Doctors Wallsten Medical Group |
| Information provided by: | Engineers & Doctors Wallsten Medical Group |
| ClinicalTrials.gov Identifier: | NCT00270504 |
Purpose
The purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.
| Condition | Intervention | Phase |
|
Urethral Stricture |
Device: Memokath stenting |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Prospective, Randomized, Controlled, Multicenter Trial of the Memokath® 044TW Thermo-Expandable Stent for Maintaining Urethral Patency in Patients After Dilation or Internal Urethrotomy of Recurrent Stricture of the Bulbar Urethra |
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2002 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. All patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. The stent is removed at one year. In case of premature stent removal the patient is also followed for up to one year unless further intervention is decided.
Control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.
Eligibility
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Recurrent stricture of the bulbar urethra:
Exclusion Criteria:
Strictures:
Contacts and Locations| Contact: Gerald H Jordan, M.D. | 757-457-5125 | ghjordan@sentara.com |
| Contact: Kim Ramsey, RN | 757-457-5125 | kramsey@urologyofva.com |
| United States, California | |||||
| Jack McAninch | Recruiting | ||||
| San Francisco, California, United States, 94110 | |||||
| Contact: Jack McAninch, M.D. 415-476-3372 jwm@itsa.ucsf.edu | |||||
| Contact: Layla A Mario (415) 476-3372 layla@itsa.ucsf.edu | |||||
| Principal Investigator: Jack McAninch, M.D. | |||||
| United States, Mississippi | |||||
| Mississippi Urology | Completed | ||||
| Jackson, Mississippi, United States, 39202 | |||||
| United States, Ohio | |||||
| Cleveland Clinic | Terminated | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| United States, Pennsylvania | |||||
| Bryn Mawr Urology | Recruiting | ||||
| Bryn Mawr, Pennsylvania, United States, 19010 | |||||
| Contact: James Squadrito, M.D. 610-525-6580 Drsquad@aol.com | |||||
| Contact: Matt Soroush, M.D. 610-525-6580 mattsoroush1@yahoo.com | |||||
| Principal Investigator: James Squadrito, M.D. | |||||
| Sub-Investigator: Matt Soroush, M.D. | |||||
| United States, Rhode Island | |||||
| University Urological Associates | Terminated | ||||
| Providence, Rhode Island, United States, 02904 | |||||
| United States, Virginia | |||||
| Devine-Tidewater Urology | Recruiting | ||||
| Norfolk, Virginia, United States, 23510 | |||||
| Principal Investigator: Gerald H Jordan, M.D. | |||||
| United States, Washington | |||||
| Harborview Medical Center | Recruiting | ||||
| Seattle, Washington, United States, 98104 | |||||
| Contact: Hunter Wessells, M.D. 206-731-3205 wessells@u.washington.edu | |||||
| Contact: Kay Longhi, RN (206) 731-8230 clonghi@u.washington.edu | |||||
| Principal Investigator: Hunter Wessells, M.D. | |||||
| Sub-Investigator: Elisabeth A Miller, M.D. | |||||
| Engineers & Doctors Wallsten Medical Group |
| Principal Investigator: | Gerry Jordan, MD | Sentara/Engineers and Doctors |
More Information
| Responsible Party: | Engineers and Doctors Inc ( Director of Clinical and Regulatory ) |
| Study ID Numbers: | 1-044TWUS, GO20135 |
| First Received: | December 23, 2005 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00270504 |
| Health Authority: | United States: Food and Drug Administration |
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