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Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management

NCT03738566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-05-24

Study results available
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Summary

This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.

Conditions

  • Esophageal Dilation
  • Refractory Benign Esophageal Stricture

Interventions

DEVICE

Esophageal self-dilation therapy

Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.

PROCEDURE

Endoscopic therapy with esophageal dilation

A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Alexander, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2021-07-02
Completion
2022-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03738566 on ClinicalTrials.gov