Trial document




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  DRKS00018996

Trial Description

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Title

Bougie CAP in the treatment of benign oesophagus stenosis: randomised controlled pilot study

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Trial Acronym

BOUGIE-PED

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study evaluates, if the newly developed over the scope BougieCap (Ovesco, Tübingen, Germany) for treatment of benign oesophageal stenosis is more beneficial and causes less complications than the actual standard therapy in children.

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Brief Summary in Scientific Language

This randomised, multi centric, and prospective pilot study evaluates the treatment of benign oesophagus stenosis with Bougie Cap (Ovesco, Tübingen, Germany) versus standard therapy with Savary bougies or balloon dilatation in children. A successful treatment is defined as opening the stenosis by dilatation and passing though the stenosis. After informed consent and randomisation the patients were dilated either by the Bougie Cap method or the common standard treatment of the center. Patients and caregivers are blinded. Efficacy, complications, dysphagy score and quality of life are documented during the study.

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Organizational Data

  •   DRKS00018996
  •   2019/10/14
  •   [---]*
  •   yes
  •   Approved
  •   102/19, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1241-6233 
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Health Condition or Problem studied

  •   K22.2 -  Oesophageal obstruction
  •   K20 -  Oesophagitis
  •   K21.0 -  Gastro-oesophageal reflux disease with oesophagitis
  •   K91.83 -  [generalization K91.8: Other postprocedural disorders of digestive system, not elsewhere classified]
  •   Q39 -  Congenital malformations of oesophagus
  •   Q87 -  Other specified congenital malformation syndromes affecting multiple systems
  •   T28.6 -  Corrosion of oesophagus
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Interventions/Observational Groups

  •   Dilatation with Bougie Cap
  •   Dilatation with standard method (Savary Bougie, or Ballon Dilatation).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

successful opening of the stricture and passing though (yes or no)

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Secondary Outcome

QoL-Analysis (Sibergliet A. et al The dysphagia handicap index) before treatment, 1 and 14 days after treatment, Dysphagia-Score (BODS-2 Questionnaire) before treatment, 1 and 14 days after treatment, Duration of intervention (in minutes), need for change to another interventional method (Yes/No; and which), duration of Sedation (in minutes)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/10/15
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Age below 18 years with benign Stenosis and informed consent of the parents

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Exclusion Criteria

Missing informed consent, untreatable Stenosis

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Addresses

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Sources of Monetary or Material Support

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    • Klinik für Kinder- und Jugendmedizin Universitätsklinikum Ulm
    • Mr.  PD Dr. med.  Carsten  Posovszky 
    • Eythstr. 24
    • 89075  Ulm
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Beobachtungsplan
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* This entry means the parameter is not applicable or has not been set.