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Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604523
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
David Cave, University of Massachusetts, Worcester

Brief Summary:

The purpose of the study is to prospectively evaluate the most effective treatment of esophageal dysmotility that alleviates symptoms of dysphagia and improves quality of life.

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.


Condition or disease Intervention/treatment Phase
Esophageal Dysmotility Device: Dilation by Balloon Device: Dilation by Semi-rigid Savary Not Applicable

Detailed Description:

Both the Savary and balloon dilators are used as routine procedure at University of Massachusetts (UMass) Medical School's academic medical center UMass Memorial Health Care (UMMHC). Gastroenterologists are required as part of their training to be familiar with both types of procedures. This study aims to definitively determine which treatment method is more effective in alleviating the symptoms of esophageal dysmotility.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants are randomized to procedure, but if participant fails the first procedure they are given the opportunity to crossover to the other arm for a follow up procedure.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Semi-rigid Savary Dilators vs. Balloon Dilators During Esophageal Dilation in the Treatment of Esophageal Dysmotility
Actual Study Start Date : August 14, 2014
Estimated Primary Completion Date : August 13, 2020
Estimated Study Completion Date : August 13, 2020

Arm Intervention/treatment
Active Comparator: Dilation by Balloon
Esophageal dilation by balloon device.
Device: Dilation by Balloon
Esophageal dilation by balloon device.

Active Comparator: Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device.
Device: Dilation by Semi-rigid Savary
Esophageal dilation by semi-rigid savary device




Primary Outcome Measures :
  1. Therapeutic efficacy as measured by change in Dysphagia Scale score [ Time Frame: Baseline to 6 months post-procedure ]
    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).


Secondary Outcome Measures :
  1. Time to Relapse [ Time Frame: Initial intervention to second dilation or 6 months ]
    Measure of time to relapse based on time from procedure to need for additional dilation due to subsidence of therapeutic effect of procedure.

  2. Diet Improvement [ Time Frame: baseline to 6 months post procedure ]
    Diet improvement based on change to Cox diet score

  3. SF-12 Health Survey [ Time Frame: baseline to 6 months ]
    changes in quality of life based upon score on SF-12 Health Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • Dysphagia to liquids and/or solids
  • Diagnosis of esophageal dysmotility
  • Normal endoscopic exam

Exclusion Criteria:

  • Diagnosis of achalasia
  • Defined strictures or webs
  • Vulnerable populations:
  • Adults unable to consent (Individuals who are not yet adults (infants, children, teenagers), Pregnant women, Prisoners)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604523


Contacts
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Contact: Anne Foley IBDClinicalTrials@umassmed.edu

Locations
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United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Anne Foley       IBDClinicalTrials@umassmed.edu   
Principal Investigator: David Cave, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: David Cave, MD Professor of Medicine, UMass Medical School
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Responsible Party: David Cave, Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03604523    
Other Study ID Numbers: H00004174
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases