Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000165

Trial Description

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Title

Transurethral En-Bloc Resection of Urothelial Bladder Carcinoma using combined high-pressure-waterjet-technology and high frequency surgery

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The present study evaluates Feasibility and Safety of the new possibility for an En-Bloc resection of non-muscle-invasive urothelial bladder carcinomas.

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Brief Summary in Scientific Language

The present study evaluates Feasibility and Safety of the new possibility for an En-Bloc resection of non-muscle-invasive urothelial bladder carcinomas. Hypothetic scientific benefit is the compliance of the oncologic-surgical principle in bladder cancer: to cut in normal tissue and to resect the tumour completely in one piece. Maybe this technique leads to a reduction of post-surgically circulating cancer cells within the urine and consecutively to a reduced recurrence rate of urothelial bladder cancer.

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Organizational Data

  •   DRKS00000165
  •   2011/08/05
  •   [---]*
  •   yes
  •   Approved
  •   09/063, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   U1111-1122-5528 
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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   The urothelial carcinomas are dissected by the HybridKnife, a wire with a microcapillary lumen by which a water beam with a pressure of 30bar is applicated. The tumours are elevated and dissected by common diathermy, which is also applicated by the HybridKnife.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

End points of the study: application criteria (feasibility, time), complication rate; time of assessment ranges from the surgery to 3d postoperatively, acquired by clinical documentation.

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Secondary Outcome

Feasibility of histopathologic evaluation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/08/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

patients with cystoscopically suspicious findings for papillary bladder cancer

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Exclusion Criteria

- recent instillation therapy
- localisation at the dome, side or anterior wall of the bladder
- diameter >3cm

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Urologie Universität Regensburg Caritas-Krankenhaus St.Josef
    • Mr.  Prof. Dr.  Wolf Ferdinand  Wieland 
    • Landshuter Str. 65
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Urologie der Universität Regensburg am Caritas-Krankenhaus St.Josef
    • Mr.  Dr. med.  Hans-Martin  Fritsche 
    • Landshuter Str. 65
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Urologie der Universität Regensburg am Caritas-Krankenhaus St.Josef
    • Mr.  PD Dr.  Hans-Martin   Fritsche 
    • Landshuter Str. 65
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Urologie der Universität Regensburg am Caritas-Krankenhaus St.Josef
    • Landshuter Str. 65
    • 93053  Regensburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.