Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000627

Trial Description

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Title

Selective Tissue elevation by pressure injection

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Trial Acronym

STEP I

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The trial is for patients with benign tumors which are going to be resected local.
Instead of the elevation of the submucosa with convential needle a needleless system is used for better resection of the tumor.

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Brief Summary in Scientific Language

Aim of the study is to proof the usefullness of needlless elavation of the submucoa with the hydrojet for EMR and ESD.

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Organizational Data

  •   DRKS00000627
  •   2010/12/06
  •   [---]*
  •   yes
  •   Approved
  •   2006-121N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1118-3501 
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Health Condition or Problem studied

  •   D12.6 -  Benign neoplasm: Colon, unspecified
  •   D12.8 -  Benign neoplasm: Rectum
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Interventions/Observational Groups

  •   mucosa elevation with the hydrojet followed by endoscopic mucosa resection (EMR)
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Characteristics

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

Feasability

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Secondary Outcome

complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2006/09/20
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

yamada I or II leasion
patient over 18 years

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Exclusion Criteria

Manifest coagulation disorder
-prothrombin time <65%, pTT >40sec, thrombocytes > 50000

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Addresses

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    • Universitätsmedizin Mannheim Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  Prof.   Georg  Kähler 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin Mannheim Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  Prof.   Georg  Kähler 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Mannheim Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Ms.  Anja  Schmitt 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Mannheim Zentrale Interdisziplinäre Endoskopie Medizinische Fakultät Mannheim der Universität Heidelberg
    • Mr.  Prof.   Georg  Kähler 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/08/22
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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.