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Endoscopical Dilation of Benign Esophageal Strictures

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ClinicalTrials.gov Identifier: NCT01738997
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Dysphagia Device: Dilation 10 sec Device: Dilation 2 min

Study Design

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
Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Eligibility Criteria

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
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 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:
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