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Sponsored by: |
University Hospital, Bordeaux |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00790686 |
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.
Condition | Intervention | Phase |
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Ureteral Obstruction |
Procedure: Insertion of Memokath 051 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter |
Estimated Enrollment: | 30 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Memokath 051
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Procedure: Insertion of Memokath 051
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy.
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Introduction:
The chronic strictures of the ureter are usually treated by double J stents. They allow the emptying of the kidney and avoid the deterioration of renal function. Unfortunately, double J stents have to be replaced every 6 month and are at the origin of irritative lower urinary tract symptoms and lumbar pain which corrupt the quality of life of the patients.
Ureteral stricture could also be treated with MEMOKATH 051. These new ureteral stents seem not to require iterative changes and also not to cause irritative symptoms and lombar pain. MEMOKATH 051 could therefore allow to reduce the number of changes and to ameliorate the quality of life of the patients.
Main objective:
Main objective is to assess effectiveness and tolerance of the MEMOKATH ® 051 in the treatment of chronic strictures of the ureter.
Resume:
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy.
After this procedure, the patients will have medical examination, blood exams, radiography and renal sonography at 1 month, 3 month and every 6 month during a 3 years follow up period.
If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent and an adverse event will be declared.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gregoire Robert, MD | +33 5 56 79 55 35 | gregoire.robert@chu-bordeaux.fr |
France | |
Department of Urology, University Hospital, Bordeaux | |
Bordeaux, France, 22076 |
Principal Investigator: | Gregoire Robert, MD | University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux ( Jean-Pierren LEROY / Clinical Research and Innovation Director ) |
Study ID Numbers: | CHUBX2008/24 |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790686 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Ureteral obstruction Urologic surgical procedure Stents Endoscopy Urology |
Urologic Diseases Ureteral Obstruction Ureteral Diseases Constriction, Pathologic |