Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
NCT ID: NCT03604523
Last Updated: 2021-04-13
Study Results
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View full resultsBasic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2014-08-14
2016-11-26
Brief Summary
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Current practice uses either semi-rigid Savary dilators or balloon dilators for esophageal dilation to treat dysphagia due to esophageal dysmotility. The study aims to show which treatment method is more effective in alleviating symptoms, since there are no other treatments available. The null hypothesis is that there is no difference between the clinical benefits of each treatment.
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Detailed Description
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The primary clinical endpoint is to assess the therapeutic efficacy of different types of dilators in an esophageal dilation procedure in patients with esophageal dysmotility. This will be evaluated through the use of the dysphagia scale (Knyrim et al, 1993). The secondary aims are to assess time to relapse, diet improvement, as well as change in quality of life. Investigators will determine time to relapse by time between the dilation procedures. Participants are instructed to contact the GI office to schedule another dilation if they feel as though the therapeutic effect of the procedure has subsided and they are in need of additional relief. Diet will be assessed using the diet score (Cox et al, 1998) and quality of life will be assessed using the Short Form (SF) SF-12 Health Survey.
If patients fail the first procedure, they can be offered the alternative procedure at a later date. Both the patient and physician must agree that the treatment has not worked, and then the patient will be given the opportunity to cross over to the other procedure, still blinded to the device that will be used. Investigators will conduct an interim evaluation to assess the progress of the study and degree of crossover. This will ensure that all subjects are given the opportunity to have both devices used in the event that one is significantly superior to the other.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dilation by Balloon
Esophageal dilation by balloon device.
Dilation by Balloon
Esophageal dilation by balloon device.
Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device.
Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device
Interventions
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Dilation by Balloon
Esophageal dilation by balloon device.
Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device
Eligibility Criteria
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Inclusion Criteria
* Dysphagia to liquids and/or solids
* Diagnosis of esophageal dysmotility
* Normal endoscopic exam
Exclusion Criteria
* Defined strictures or webs
* Vulnerable populations:
* Adults unable to consent (Individuals who are not yet adults (infants, children, teenagers), Pregnant women, Prisoners)
18 Years
ALL
No
Sponsors
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University of Massachusetts, Worcester
OTHER
Responsible Party
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David Cave
Professor
Principal Investigators
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David Cave, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine, UMass Medical School
Locations
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UMass Memorial Medical Center
Worcester, Massachusetts, United States
Countries
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Other Identifiers
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H00004174
Identifier Type: -
Identifier Source: org_study_id
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