Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter

Recruitment status:
Not recruiting
Primary Sponsor:
University Hospital, Bordeaux
Recruitment countries:
France
Health condition studied:
Ureteral Obstruction
URL:
Link to the clinical trial website

About the trial

Interventions:
Procedure: Insertion of Memokath 051
Key inclusion and exclusion criteria:

  • 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
  • Age minimum:  18 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Average durability of the stent MEMOKATH ® 051
Secondary outcomes:
Average quality of life of the patients measured by auto-questionary
Expense of hospitalizations for replacement of the ureteral stent
Proportion of patients to which the ureteral stent was definitely taken away
Proportion of replacement of the ureteral stent
Proportion of ureteral stent MEMOKATH ® 051 positioning failure
Target sample size:
13
Study type:
Interventional
Study design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Contacts:
  • Name:   Antoine BENARD, MD
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  University Hospital, Bordeaux
  • Name:   Gregoire Robert, MD
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  University Hospital, Bordeaux

Technical details

Scientific title:
Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT00790686
Secondary ID:
CHUBX2008/24
Register:
ClinicalTrials.gov
Date of registration:
12/11/2008
Date of first enrollment:
November 2008
Last refreshed:
1 September 2014

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