Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation

NCT03604523 | Terminated Results FDA Device

• 1 other identifier: H00004174
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Dysmotility

Outcome Measures

Primary Outcomes (1)

• Therapeutic Efficacy as Measured by Change in Dysphagia Scale Score

  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 1993). Minimum score is 0. Maximum score is 4. Higher scores indicate a worse outcome. The data presented represent a change from baseline to 6 months calculated as the value at 6 months minus the value at baseline.

  Baseline to 6 months post-procedure

Secondary Outcomes (3)

• Participants With Relapse

  Baseline to 6 months

• Time to Relapse

  Initial intervention to second dilation

• Diet Dysphagia Score Change

  baseline to 6 months post procedure

Study Arms (2)

Dilation by Balloon

ACTIVE COMPARATOR

Esophageal dilation by balloon device.

Device: Dilation by Balloon

Dilation by Semi-rigid Savary

ACTIVE COMPARATOR

Esophageal dilation by semi-rigid savary device.

Device: Dilation by Semi-rigid Savary

Interventions

Dilation by Balloon DEVICE

Esophageal dilation by balloon device.

Dilation by Balloon

Dilation by Semi-rigid Savary DEVICE

Esophageal dilation by semi-rigid savary device

Dilation by Semi-rigid Savary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Recruitment was much slower than planned and the study was terminated early with only 15.6% of overall study goal enrolled. Early termination led to small numbers of subjects analyzed. Subjects unable to be reached for followup led to missing data for outcome measures.

Results Point of Contact

• Title: Dr. David Cave
• Organization: UMass Medical School

david.cave@umassmemorial.org

508-856-8399

Study Officials

• David Cave, MD

  Professor of Medicine, UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 27, 2018
• Study Start: August 14, 2014
• Primary Completion: November 26, 2016
• Study Completion: November 26, 2016
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)