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Pragmatic Approach To Esophageal Dilation

NCT04542551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-01-05

No results posted yet for this study

Summary

The purpose of this study is to better understand the role of a technique called esophageal dilation in patients who complain of trouble swallowing. In patients with esophageal stricture we want to determine if the size of the esophageal dilator makes a difference in symptoms and outcomes. In patients who do not have an obvious esophageal stricture we want to determine if esophageal dilation is an effective therapy in these patients.

Conditions

Interventions

PROCEDURE

Dilation 60-Fr non stricture

Dilation of patients with subjective dysphagia and normal endoscopy

PROCEDURE

Sham

Sham dilator for patients with subjective dysphagia and normal endoscopy

PROCEDURE

Non severe stricture - dilation with 60-Fr

Dilation of non severe stricture with 60-Fr dilator

PROCEDURE

Non severe stricture - dilation with 46-Fr

Dilation of non severe stricture with 46-Fr dilator

PROCEDURE

Severe stricture - dilation with 51-Fr

Dilation of a severe stricture with 51-Fr dilator

PROCEDURE

Severe stricture - dilation with 42-Fr

Dilation of a severe stricture with 42-Fr dilator

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Stephen McClave, MD · University of Louisville School of Medicine

  • Benjamin Rogers, MD · University of Louisville School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2023-10-17
Completion
2023-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04542551 on ClinicalTrials.gov