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Esophageal Dilation for Swallowing Disorders

N/A
Waitlist Available
Led By Stephen McClave, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with esophageal dysphagia who are 18 years old or older.
Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Awards & highlights

Study Summary

This trial is studying how well esophageal dilation works in patients with or without an esophageal stricture.

Who is the study for?
This trial is for adults over 18 with swallowing disorders who are undergoing an esophagus examination (EGD). It's suitable for those with known narrowings in their esophagus, whether or not they've been stretched before. Participants must be able to consent to the study.Check my eligibility
What is being tested?
The study tests if stretching the esophagus helps with swallowing difficulties. Different sizes of dilators are used depending on whether patients have a severe stricture (narrowing) or not, including some receiving sham treatments as a comparison.See study design
What are the potential side effects?
Possible side effects from esophageal dilation may include sore throat, pain when swallowing, chest pain, and very rarely, tears in the esophagus which would require immediate medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of complete relief of dysphagia
Change in ability to tolerate diet in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by diet score.
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
+2 more
Secondary outcome measures
Dilation sessions required to achieved sustainable change in dysphagia and diet score
Duration of sustained change between sessions
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Without stricture - dilation with 60-FrActive Control1 Intervention
Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator
Group II: Non severe stricture - dilation with 46-FrActive Control1 Intervention
Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator
Group III: Severe stricture - dilation with 51-FrActive Control1 Intervention
Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator
Group IV: Non severe stricture - dilation with 60-FrActive Control1 Intervention
Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator
Group V: Severe stricture - dilation with 42-FrActive Control1 Intervention
Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator
Group VI: Without stricture - dilation with 15-FrPlacebo Group1 Intervention
Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
336 Previous Clinical Trials
75,906 Total Patients Enrolled
Stephen McClave, MDPrincipal InvestigatorUniversity of Louisville School of Medicine
Benjamin Rogers, MDStudy ChairUniversity of Louisville School of Medicine

Media Library

Dilation 60-Fr non stricture Clinical Trial Eligibility Overview. Trial Name: NCT04542551 — N/A
Swallowing Difficulty Research Study Groups: Without stricture - dilation with 60-Fr, Without stricture - dilation with 15-Fr, Non severe stricture - dilation with 46-Fr, Severe stricture - dilation with 51-Fr, Non severe stricture - dilation with 60-Fr, Severe stricture - dilation with 42-Fr
Swallowing Difficulty Clinical Trial 2023: Dilation 60-Fr non stricture Highlights & Side Effects. Trial Name: NCT04542551 — N/A
Dilation 60-Fr non stricture 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542551 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities available to join this research project?

"Affirmative, the information published on clinicaltrials.gov attests to this medical experiment's ongoing recruitment process. The trial was inaugurated on March 24th 2021 and has been recently revised April 23rd 2022. 168 individuals are required between 3 distinct research sites."

Answered by AI

How many participants are being offered participation in this research project?

"Affirmative. Per the information offered on clinicaltrials.gov, this medical trial is currently recruiting patients. The first posting was made on March 24th 2021 and the latest update happened April 23rd 2022. This study aims to find 168 participants from 3 different medical facilities."

Answered by AI
~8 spots leftby Mar 2025