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Non-invasive Esophageal Testing for Swallowing Disorders

N/A

Waitlist Available

Led By Dhyanesh Patel, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults ≥ 18 years of age who are undergoing HRM for routine standard of care evaluation for esophageal motility.

Normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications.

Must not have

Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a new way to measure electrical activity in the esophagus to understand how it works and if it is a noninvasive option.

Who is the study for?

This trial is for adults over 18 with no gastrointestinal issues, or those getting routine checks for esophageal motility. It's not for people with MRI contraindications like pacemakers, severe obesity, heart rhythm problems, anticoagulant use, or claustrophobia.

What is being tested?

The study tests noninvasive methods to record esophageal activity in adults using EESG and MESG alongside High resolution manometry (HRM), which are techniques to measure muscle function and movements of the esophagus.

What are the potential side effects?

Since this trial involves non-invasive monitoring techniques rather than medication or invasive procedures, significant side effects are not expected. However, discomfort from lying still during measurements may occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older and getting an HRM test for esophagus issues.

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I am over 18 and do not have any known stomach or intestine problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of heart rhythm problems nor am I on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Presence of diagnostic pattern

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Achalasia subjectsActive Control4 Interventions

Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Group II: Hypercontractile/spastic disorder subjectsActive Control4 Interventions

Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Group III: Healthy ControlsActive Control3 Interventions

Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

0 / 3Eligibility criteria met