Trial document





This trial has been registered retrospectively.
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  DRKS00009886

Trial Description

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Title

Transoral endoscopic mediastinal surgery (TOEMS) for mediastinal lymph node biopsies - clinical phase I study.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Phase I feasability study for the assessement of a scareless transoral operating procedure for the diagnosis of mediastinal lymphadenopathy.

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Brief Summary in Scientific Language

Conventional mediastioscopy is performed through an incision at the anterior neck. In our previous studies using cadavers and an animal model in pigs we established a scarless transoral access to the mediastinum. The clinical study will show whether the transoral access to the mediastinum is feasible and safe in patients with mediastinal lymphadenopathy.

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Organizational Data

  •   DRKS00009886
  •   2016/01/15
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  •   yes
  •   Approved
  •   Eth-02/10, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   D38.3 -  Neoplasm of uncertain or unknown behaviour: Mediastinum
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Interventions/Observational Groups

  •   Single arm study without control group (phase I). In this study a scarless access for mediastinoscopy will be tested. This new approach for mediastinoscopy is based on transoral orifice endoscopic surgery (NOTES) which will be performed through mouth cavity.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   I
  •   N/A
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Primary Outcome

Safety.
All adverse events (AEs) and severe adverse advents (SAEs) will be monitored and recorded by the investigators. An AE is any unfavourable and unintended sign, symptom, or disease that occurs after starting treatment, regardless of whether the event is considered related or unrelated to the study intervention. The severity of each AE will be assessed using the following grading scale (CTCAE version 4.03: June 14, 2010):
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living
Grade 4: Life-threatening consequences; urgent intervention indicated
Grade 5: Death
The investigators will inform the ethics committee about SAEs.

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Secondary Outcome

Accessibility of mediastinal lymph nodes by transoral surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2010/10/23
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Unclear mediastinal lymphadenopathy which was not resolved by prior bronchoscopy. 2. Written informed consent.

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Exclusion Criteria

1. Superior vena cava syndrome. 2. Palsy of recurrent nerve. 3. Previous operation of thyreoid gland.

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Addresses

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    • Evangelische Lungenklinik Berlin
    • Lindenberger Weg 27
    • 13125  Berlin
    • Germany
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    • Evangelische Lungenklinik Berlin
    • Mr.  Dr. med.  Wolfram  Klemm 
    • Lindenberger Weg 27
    • 13125  Berlin
    • Germany
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    • Evangelische Lungenklinik Berlin
    • Mr.  Dr.  Wolfram  Klemm 
    • Lindenberger Weg 27
    • 13125  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • KARL STORZ GmbH & Co. KG
    • Dr. Karl-Storz-Straße 34
    • 78532  Tuttlingen
    • Germany
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    • inomed Medizintechnik GmbH
    • Im Hausgrün 29
    • 79312  Emmendingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/17
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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.