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Endoscopical Dilation of Benign Esophageal Strictures

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. Identifier: NCT01738997
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Uppsala University
Boston Scientific Corporation
Information provided by (Responsible Party):
Bengt Wallner, University Hospital, Umeå

Brief Summary:
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 or disease Intervention/treatment Phase
Dysphagia Device: Dilation 10 sec Device: Dilation 2 min Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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.
Study Start Date : December 2003
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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

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

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Responsible Party: Bengt Wallner, MD, PhD, University Hospital, Umeå Identifier: NCT01738997    
Other Study ID Numbers: Dnr 02-499
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012
Keywords provided by Bengt Wallner, University Hospital, Umeå:
Esophageal strictures
Balloon Dilation
Additional relevant MeSH terms:
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Esophageal Stenosis
Constriction, Pathologic
Dilatation, Pathologic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical