DysphagiaNCT04542551

Pragmatic Approach To Esophageal Dilation

A study testing Dilation 60-Fr non stricture, Non severe stricture - dilation with 60-Fr and Non severe stricture - dilation with 46-Fr in people with Dysphagia and Swallowing Disorders, run by University of Louisville at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysphagia, Swallowing Disorders
What is being tested?: Dilation 60-Fr non stricture, Non severe stricture - dilation with 60-Fr and Non severe stricture - dilation with 46-Fr
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 3 sitesUnited States
Study dates: 24 Mar 2021to 15 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with esophageal dysphagia who are 18 years old or older.
Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
Patients who are able to provide consent for the study.
Patients with known esophageal stricture that may have or may not have been dilated before.

Who cannot join

Patients with malignant stricture.
Pregnant women.
Patients with a personal history of esophageal perforation.
Patients with achalasia, or globus sensation.
Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Louisville Hospital
Louisville, Kentucky, 40202
UofL health - Jewish hospital downtown
Louisville, Kentucky, 40202
Louisville VA Medical Center
Louisville, Kentucky, 40206

Other trials in United States

About this study

Conditions: Dysphagia, Swallowing Disorders
Being tested: Dilation 60-Fr non stricture, Sham, Non severe stricture - dilation with 60-Fr, Non severe stricture - dilation with 46-Fr, Severe stricture - dilation with 51-Fr
Keywords: Dysphagia, Swallowing Disorders, Empirical dilation, Dilation, Dysphagia score, Diet score
Medical subject headings: Deglutition Disorders, Dilatation, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dilation 60-Fr non strictureProcedure or surgery
Dilation of patients with subjective dysphagia and normal endoscopy
ShamProcedure or surgery
Sham dilator for patients with subjective dysphagia and normal endoscopy
Non severe stricture - dilation with 60-FrProcedure or surgery
Dilation of non severe stricture with 60-Fr dilator
Non severe stricture - dilation with 46-FrProcedure or surgery
Dilation of non severe stricture with 46-Fr dilator
Severe stricture - dilation with 51-FrProcedure or surgery
Dilation of a severe stricture with 51-Fr dilator
Severe stricture - dilation with 42-FrProcedure or surgery
Dilation of a severe stricture with 42-Fr dilator

Study groups in NCT04542551
Study group	Role	What they receive
Without stricture - dilation with 60-Fr	Active comparator	Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator Receives: Procedure: Dilation 60-Fr non stricture
Without stricture - dilation with 15-Fr	Sham comparator	Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham) Receives: Procedure: Sham
Non severe stricture - dilation with 60-Fr	Active comparator	Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator Receives: Procedure: Non severe stricture - dilation with 60-Fr
Non severe stricture - dilation with 46-Fr	Active comparator	Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator Receives: Procedure: Non severe stricture - dilation with 46-Fr
Severe stricture - dilation with 51-Fr	Active comparator	Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator Receives: Procedure: Severe stricture - dilation with 51-Fr
Severe stricture - dilation with 42-Fr	Active comparator	Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator Receives: Procedure: Severe stricture - dilation with 42-Fr

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients without strictures undergoing empiric dilation.
Measured: Baseline, every 8 weeks for 12 months
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients without strictures undergoing empiric dilation.
Measured: Baseline, every 8 weeks for 12 months
Change in subjective symptoms of dysphagia 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 dysphagia score.
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) 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.
Measured: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
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.
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) 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.
Measured: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Achievement of complete relief of dysphagia
Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.
Measured: End of study (12 months)

Secondary outcomes (3)

Dilation sessions required to achieved sustainable change in dysphagia and diet score
Evaluate the number of dilation sessions needed to achieve sustainable change in dysphagia and diet scores in patients with non-severe and severe stricture.
Measured: End of study (12 months)
Duration of sustained change between sessions
Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.
Measured: Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation
Evaluate if more than 3 size reduction from target diameter is needed as a result of tactile resistance for subsequent dilation sessions in patients undergoing dilation for non-severe and severe stricture.
Measured: Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 202115 Dec 2023

First posted9 Sep 2020
Study start24 Mar 2021
Primary completion17 Oct 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by University of LouisvilleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04542551
Sponsor's protocol ID: 20.0632
Status last verified: Jan 2024
First submitted: 31 Aug 2020
Last updated: 5 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Planning to share data throughout the intervals for which patients will be called for response and when data available for analysis.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Not yet recruiting
Standardizing Swallow Pressure Measurements
Dysphagia
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation

All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pragmatic Approach To Esophageal Dilation
ClinicalTrials.gov ID: NCT04542551
Acronym / sponsor ID: 20.0632
Conditions: Dysphagia, Swallowing Disorders
Keywords: Dysphagia, Swallowing Disorders, Empirical dilation, Dilation, Dysphagia score, Diet score
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of LouisvilleUniversity, hospital or other
Study start: 24 Mar 2021 (actual)
Primary completion: 17 Oct 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 9 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Without stricture - dilation with 60-Fr	Active comparator	Procedure: Dilation 60-Fr non stricturePatients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator
Without stricture - dilation with 15-Fr	Sham comparator	Procedure: ShamPatients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham)
Non severe stricture - dilation with 60-Fr	Active comparator	Procedure: Non severe stricture - dilation with 60-FrPatients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator
Non severe stricture - dilation with 46-Fr	Active comparator	Procedure: Non severe stricture - dilation with 46-FrPatients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator
Severe stricture - dilation with 51-Fr	Active comparator	Procedure: Severe stricture - dilation with 51-FrPatients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator
Severe stricture - dilation with 42-Fr	Active comparator	Procedure: Severe stricture - dilation with 42-FrPatients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients with esophageal dysphagia who are 18 years old or older.
Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD).
Patients who are able to provide consent for the study.
Patients with known esophageal stricture that may have or may not have been dilated before.

Key exclusion criteria (5 listed)

Patients with malignant stricture.
Pregnant women.
Patients with a personal history of esophageal perforation.
Patients with achalasia, or globus sensation.
Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dilation 60-Fr non strictureDilation of patients with subjective dysphagia and normal endoscopy	Procedure or surgery	Without stricture - dilation with 60-Fr
ShamSham dilator for patients with subjective dysphagia and normal endoscopy	Procedure or surgery	Without stricture - dilation with 15-Fr
Non severe stricture - dilation with 60-FrDilation of non severe stricture with 60-Fr dilator	Procedure or surgery	Non severe stricture - dilation with 60-Fr
Non severe stricture - dilation with 46-FrDilation of non severe stricture with 46-Fr dilator	Procedure or surgery	Non severe stricture - dilation with 46-Fr
Severe stricture - dilation with 51-FrDilation of a severe stricture with 51-Fr dilator	Procedure or surgery	Severe stricture - dilation with 51-Fr
Severe stricture - dilation with 42-FrDilation of a severe stricture with 42-Fr dilator	Procedure or surgery	Severe stricture - dilation with 42-Fr

Primary outcome

Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
Time frame: Baseline, every 8 weeks for 12 months
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients without strictures undergoing empiric dilation.
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
Time frame: Baseline, every 8 weeks for 12 months
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients without strictures undergoing empiric dilation.
Change in subjective symptoms of dysphagia 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 dysphagia score.
Time frame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) 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.
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.
Time frame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) 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.
Achievement of complete relief of dysphagia
Time frame: End of study (12 months)
Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.

3 secondary outcomes

Dilation sessions required to achieved sustainable change in dysphagia and diet score
Time frame: End of study (12 months)
Duration of sustained change between sessions
Time frame: Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation
Time frame: Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Individual participant dataSharing planned: Yes. Planning to share data throughout the intervals for which patients will be called for response and when data available for analysis.

Related trials for Dysphagia

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Not yet recruiting
Standardizing Swallow Pressure Measurements
Dysphagia
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen McClave, MD principal investigator

University of Louisville School of Medicine

Benjamin Rogers, MD study chair

University of Louisville School of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score. (time frame: Baseline, every 8 weeks for 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.