Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter (NCT00790686) | Clinical Trial Compass
CompletedPhase 2
Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
France13 participantsStarted 2008-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-year-old or superior
* Chronic stenosis of the ureter treated by placement of a ureteral endoprosthesis for more than six months;
* No possibility for surgical or endoscopic treatment of the ureteral stricture
* Free Consent, dated and signed by the patient
* Affiliated Subject of a regime of French national health and pensions organization.
Exclusion Criteria:
* Age under 18 year old
* Pregnant or nursing Women
* Patient having a life expectancy of less than 1 year
* Patient having unique kidney
* Patient having severe renal insufficiency (creatinin clearance under 30 ml/min)
* Possible surgical or endoscopic treatment of ureteral stricture
* Repeated urinary tract stones
* Urothelial tumor of the bladder
* Retro peritoneal fibrosis in the course of evolution
* Complications of double J stents requiring more thanks a lot every 6 months
* Against anaesthetic indication
* Lithiasic inlay probe Double J with obstruction within 6 months
* Persons put under maintenance of justice
* Persons in inability to understand the sequence of try
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.