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Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation

NCT03604523 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-13

Study results available
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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.

Conditions

  • Esophageal Dysmotility

Interventions

DEVICE

Dilation by Balloon

Esophageal dilation by balloon device.

DEVICE

Dilation by Semi-rigid Savary

Esophageal dilation by semi-rigid savary device

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • David Cave, MD · Professor of Medicine, UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-14
Primary Completion
2016-11-26
Completion
2016-11-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604523 on ClinicalTrials.gov