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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604523
Recruitment Status : Terminated (Slow enrollment)
First Posted : July 27, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
David Cave, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE June 26, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE August 14, 2014
Actual Primary Completion Date November 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
  • 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.
  • Diet Improvement [ Time Frame: baseline to 6 months post procedure ]
    Diet improvement based on change to Cox diet score
  • SF-12 Health Survey [ Time Frame: baseline to 6 months ]
    changes in quality of life based upon score on SF-12 Health Survey
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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.
  • Diet Improvement [ Time Frame: baseline to 6 months post procedure ]
    Diet improvement based on change to diet score Cox et al 1998
  • SF-12 Health Survey [ Time Frame: baseline to 6 months ]
    changes in quality of life based upon score on SF-12 Health Survey
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
Official Title  ICMJE Effectiveness of Semi-rigid Savary Dilators vs. Balloon Dilators During Esophageal Dilation in the Treatment of Esophageal Dysmotility
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Esophageal Dysmotility
Intervention  ICMJE
  • Device: Dilation by Balloon
    Esophageal dilation by balloon device.
  • Device: Dilation by Semi-rigid Savary
    Esophageal dilation by semi-rigid savary device
Study Arms  ICMJE
  • Active Comparator: Dilation by Balloon
    Esophageal dilation by balloon device.
    Intervention: Device: Dilation by Balloon
  • Active Comparator: Dilation by Semi-rigid Savary
    Esophageal dilation by semi-rigid savary device.
    Intervention: Device: Dilation by Semi-rigid Savary
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 10, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2018)
64
Actual Study Completion Date  ICMJE November 26, 2016
Actual Primary Completion Date November 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604523
Other Study ID Numbers  ICMJE H00004174
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Cave, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Cave, MD Professor of Medicine, UMass Medical School
PRS Account University of Massachusetts, Worcester
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP