Trial document




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  DRKS00007951

Trial Description

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Title

Prospective,randomized clinical trial for homeostasis via hemospray after endoscopic resection in the upper gastrointestinal tract

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Adenomas represent the majority of occurring benign tumors of the upper gastrointestinal tract. Although they are classified as benign, they have the potential for malignant transformation Endoscopic resection allows the patient to minimal invasive therapy with good results without the risks of surgery with general anesthesia.Any intervention also goes hand in hand with complications. Severe complications (bleeding and perforation) are, for example, specified in the duodenum with up to 9%. The overall rate of bleeding complications is up to 25% Hemospray © (Cook Medical, Winston-Salem, North Carolina, United States) is a powder for care of acute upper gastrointestinal bleeding. After endoscopic application makes it through contact with the mucous membrane a barrier and leads to hemostasis. In acute bleeding upper gastrointestinal bleeding in 97% of cases by © Hemospray could be stopped .
The application of Hemosprays after endoscopic resection may address the acute hemostasis also contributing to post-interventional bleeding that occur frequently, werden.Diese prevents study aims hemostasis by Hemospray © after endoscopic resection of large (≥20mm) lesions in the gastrointestinal tract to investigate.

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Brief Summary in Scientific Language

This clinical trail is to investigate the target hemostasis by Hemospray © after endoscopic resection of large ( ≥20mm ) lesions in the gastrointestinal tract . Besides acute hemostasis , especially the risk reduction of post- interventional bleeding should be investigated.

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Organizational Data

  •   DRKS00007951
  •   2015/07/02
  •   [---]*
  •   yes
  •   Approved
  •   ff 55/2014 , Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   C26.9 -  Malignant neoplasm: Ill-defined sites within the digestive system
  •   Hemostasis after endoscopic resection of polyps in the stomach and duodenum
  •   hemostasis
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Interventions/Observational Groups

  •   Patients after endoscopic resection with bleeding is Hemospray applied for hemostasis
  •   conventional hemostasis
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The main objective of the study is to investigate whether an application of Hemospray © bleeding complication after endoscopic resection may reduce upper GI. Hemospray © Company Cook is already used in the therapy of acute bleeding complications of the upper and lower gastrointestinal tract. The question is whether the high rate is influenced to bleeding complications and postintervention bleeding. In steady course all occurring complications can be detected accurately, distinguishing between complications within the first 24 hours after surgery and complications occurring later. ,
In addition, a re-EGD is in each patient the day after the intervention performed in order to assess the wound surface, possibly to detect emerging local bleeding and endoscopically to breastfeed and possibly to treat small residual Adenomreste after. Again, any findings and any re-intervention in the frame of the documents.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/07/05
  •   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

- Patients older than 18 years
- Patients with a lesion in the upper gastrointestinal tract and medical indication for resection .
- Bleeding complications ( bleeding Sure , spurting bleeding or bleeding with visible vessel )

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Exclusion Criteria

- Lack of consent
- Pregnancy
- Coagulation disorders ( Quick < 60 % , PTT > 50s , platelets < 100,000 / nl )
- Taking antiplatelet < 7 days.
- Taking an oral anticoagulation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Sana Klinikum Offenbach
    • Mr.  Prof. Dr. med.  Christian  Ell 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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    •   06984953971
    •   [---]*
    •   [---]*
    •   [---]*
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    • Sana Klinikum Offenbach
    • Ms.  Prof. Dr. med  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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    • Sana Klinikum Offenbach
    • Ms.  Prof. Dr. med  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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Sources of Monetary or Material Support

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    • Sana Klinikum Offenbach
    • Prof. Dr.   Christian  Ell 
    • Am Starkenburgring 66
    • 63069  Offenbach
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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