Trial document




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  DRKS00006283

Trial Description

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Title

Documentation of Colon capsule endoscopies - nationwide study

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Trial Acronym

DEKOR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.

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Brief Summary in Scientific Language

Prospective registration of data for an observational study

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Organizational Data

  •   DRKS00006283
  •   2014/07/17
  •   2014/06/27
  •   yes
  •   Approved
  •   265/13, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   NCT02182466  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   K63 -  Other diseases of intestine
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Interventions/Observational Groups

  •   Colon capsule endoscopy: Results of the investigation of colon capsule endoscopy, complikations and preparation of the bowel are registered
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Ratio of patients in whom a diagnosis is established by applying colon capsule endoscopy, or exclusion of pathological findings

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Secondary Outcome

technical success of colon capsule endoscopy
rate of complications during performing colon capsule endoscopy
Registration of the cleansing level of the investigation and purgatives administered

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/08/01
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Indication for colon capsule endoscopy
Age of 18 years or older
Consent of the patient

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Exclusion Criteria

Limitations of use apply according to the provider of the colon capsule system

Suspicion of intestinal obstruction in agreement with a pre-test, e.g. retiontion of the patency capsule
Dysphagia or
Pregnancy

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Addresses

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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Mr.  PD Dr  Jörg  Albert 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Mr.  Dr  Andrea  Tal 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Given Imaging GmbH Hamburg
    • Given  Imaging 
    • Borsteler Chaussee 47
    • 22453  Hamburg
    • Germany
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    •   040 5133000
    •   040 5133000
    •   [---]*
    •   [---]*
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Status

  •   Recruiting planned
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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.