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Endoscopical Dilation of Benign Esophageal Strictures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738997
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Uppsala University
Boston Scientific Corporation
Information provided by (Responsible Party):
Bengt Wallner, University Hospital, Umeå
  Purpose
Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time, with 2 minutes inflation time, regarding the efficacy

Condition Intervention
Dysphagia Device: Dilation 10 sec Device: Dilation 2 min

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.

Resource links provided by NLM:


Further study details as provided by Bengt Wallner, University Hospital, Umeå:

Primary Outcome Measures:
  • Relief from dysphagia [ Time Frame: 1 year from dilation ]

Enrollment: 20
Study Start Date: December 2003
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Dilation 10 sec
Device: Dilation 10 sec
Other Name: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
Active Comparator: Group B
Dilation 2 min
Device: Dilation 2 min
Other Name: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease

Exclusion Criteria:

  • Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Bengt Wallner, MD, PhD, University Hospital, Umeå
ClinicalTrials.gov Identifier: NCT01738997     History of Changes
Other Study ID Numbers: Dnr 02-499
First Submitted: November 28, 2012
First Posted: November 30, 2012
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Bengt Wallner, University Hospital, Umeå:
Benign
Esophageal strictures
Esophagus
Balloon Dilation

Additional relevant MeSH terms:
Constriction, Pathologic
Dilatation, Pathologic
Esophageal Stenosis
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases