Back to resultsEndoscopical Dilation of Benign Esophageal Strictures
Primary Purpose
Dysphagia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dilation 10 sec
Dilation 2 min
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Benign, Esophageal strictures, Esophagus, Balloon Dilation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Dilation 10 sec
Dilation 2 min
Outcomes
Primary Outcome Measures
Relief from dysphagia
Secondary Outcome Measures
Full Information
NCT ID
NCT01738997
First Posted
November 28, 2012
Last Updated
November 29, 2012
Sponsor
University Hospital, Umeå
Collaborators
Uppsala University, Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01738997
Brief Title
Endoscopical Dilation of Benign Esophageal Strictures
Official Title
Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Umeå
Collaborators
Uppsala University, Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Benign, Esophageal strictures, Esophagus, Balloon Dilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Dilation 10 sec
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Dilation 2 min
Intervention Type
Device
Intervention Name(s)
Dilation 10 sec
Other Intervention Name(s)
CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
Intervention Type
Device
Intervention Name(s)
Dilation 2 min
Other Intervention Name(s)
CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
Primary Outcome Measure Information:
Title
Relief from dysphagia
Time Frame
1 year from dilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Endoscopical Dilation of Benign Esophageal Strictures
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