Trial document




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  DRKS00012925

Trial Description

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Title

Effectiveness, feasibility and safety in the ablation of Barrett`s esophagus by EndoRotor.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Endoscopic treatment of early Barrett´s adenocarcinoma has been established as a two-step approach. In the first step, endoscopic resection for all visible neoplasia is carried out. In the second step, the ablation of all residual intestinal metaplasia is necessary to avoid recurrence of neoplasia or development of metachronous lesions. Thermal ablation is used as the current standard for this indication.
However, major complications for all thermal treatment is the development of post therapeutic stenosis.
The EndoRotor© device (Interscope Medical, Inc., Worcester, Massachusetts) was initially developed for endoscopic treatment of malignant or adenomatous tissue of the gastrointestinal tract.
We would like to check the efficacy as well as the feasibility of mucosal removal in the esophagus by EndoRotor, in order to be able to carry out a more effective procedure than in the past. This method is used in patients with previously already completely removed malignant changes of the esophageal mucosa.

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Brief Summary in Scientific Language

The aim of the study is to assess the efficacy and feasibility of the ablation of non-neoplastic barrett's mucosa by EndoRotor after previous endoscopic resection of premalignant or malignant mucosal and submucosal neoplasia, as well as their complication and side-effects rate.

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Organizational Data

  •   DRKS00012925
  •   2017/10/06
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  •   yes
  •   Approved
  •   FF168/2016, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   C16.9 -  Malignant neoplasm: Stomach, unspecified
  •   K22.7 -  Barrett oesophagus
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Interventions/Observational Groups

  •   Prospective pilot study for ablation by EndoRotor, to be performed in 40 patients with Barrett´s esophagus that have an indication for ablation treatment. In some cases several sessions will be necessary to complete the ablation.
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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
  •   N/A
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Primary Outcome

Safety of the EndoRotor in the ablation therapy of nonmalignant Barrett's mucosa. The complication as well as the side effects rate, such as hemorrhage (major / minor), stenosis development, perforation as well as postinterventional pain are recorded.
An endoscopically check is carried out on the first post-intervention day. Furthermore, a Hb control is carried out on the following day. Pain is documented via visual analogue scale on the intervention day as well as on the following days. (Average inpatient stay during an ablation therapy 3-4days). For assessment of stenosis as well as for continuation of the therapy an OGD (Oesophagogastroduodenoscopy) control is performed after 3 months.

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Secondary Outcome

Influencing the complication rate by the type of barrette (size, length, pre-treatment),
the necessary number of sessions until completion of the ablation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2017/10/15
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Consentable
- over 18 years
- Patients undergoing endoscopic resection of malignant or premalignant neoplasia in the barrett's mucosa for ablation therapy of the remaining non-neoplastic barrett's mucosa

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Exclusion Criteria

- missing of consent
- Pregnancy
- coagulation disorders (Quick <60%, PTT> 50s, thrombocytes <100,000 / nl)
- therapeutic use of thrombocyte aggregation inhibitors <7 days
- oral anticoagulation without the possibility of a pause

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Addresses

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    • Sana Klinikum Offenbach
    • Ms.  Prof. Dr.  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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    • Interscope INC
    • Mr.  Jeffery  Ryan 
    • 100 Grove Street Suite 108
    • 01605  Worcester
    • United States
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    • Sana Klinikum Offenbach
    • Ms.  Prof. Dr.  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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    • Sana Klinikum Offenbach
    • Ms.  Prof. Dr.  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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Sources of Monetary or Material Support

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    • Sana Klinikum Offenbach
    • Ms.  Prof. Dr.  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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    •   06984053971
    •   06984054471
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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