Non-invasive Markers of Esophageal Function in Adults

August 29, 2025 updated by: Dhyanesh Patel, Vanderbilt University Medical Center
The investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) recordings.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Dysphagia, or difficulty with swallowing, is a common symptom affecting nearly 9.4 million individuals or 4% of the US population. High resolution esophageal manometry is currently considered the gold standard test for evaluation and diagnosis of esophageal motility disorders, but given that it requires trans-nasal placement in a conscious patient, this test is highly uncomfortable and associated with significant patient dissatisfaction. There are currently no noninvasive tests or markers available to test esophageal function and motility.

In the upper gastrointestinal system, as in the heart, disruption of the electrical syncytium in disease produces measurable dysrhythmia. Recent modifications of the standard electrogastrogram (EGG) that have increased the number of leads to 25 (termed high-resolution EGG) have allowed enhanced spatio-temporal resolution of electric slow wave activity, and newer analytic techniques. Additionally, the magnetogastrogram (MGG) overcomes many of the inherent limitations of the standard EGG. The goal of this proposal is to harness similar technologies applied to the esophagus to develop high-resolution electroesophagogram (EESG) and magnetoesophagogram (MESG) as noninvasive clinical methods to quantify esophageal function and motility disorders, which could guide intervention for a large number of adult patients.

The main aims in this proposal are to develop a mathematical model of esophageal function and characterize phenotypes of esophageal motility disorders using EESG/MESG in healthy controls and esophageal dysmotility patients and determine how EESG/MESG rhythm and pattern abnormalities relate to physiologic function.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Those with claustrophobia who cannot lie still under the SQUID for the length of time required
  • Due to interference with signal acquisition, subjects with contraindication to undergoing an MRI scan as noted in the MRI Safety checklist by Vanderbilt University Medical Center (such as with heart pacemakers, metal implants, or metal chips or clips) will not undergo SQUID, but can still be eligible to do cutaneous EESG.
  • Morbid obesity (these patients are potentially unable to lie under the current generation of SQUID devices)
  • Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Controls
Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).
Other: Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
Diagnostic test: EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
Diagnostic test: MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
Other Names:
  • SQUID magnetometer
Active Comparator: Achalasia subjects
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).
Other: Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
Diagnostic test: EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
Diagnostic test: MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
Other Names:
  • SQUID magnetometer
Diagnostic test: High resolution manometry (HRM)
Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms
Active Comparator: Hypercontractile/spastic disorder subjects
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).
Other: Clinical measure questionnaires
Collection of patient reported symptoms and perception of health
Diagnostic test: EESG
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
Diagnostic test: MESG
MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
Other Names:
  • SQUID magnetometer
Diagnostic test: High resolution manometry (HRM)
Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of diagnostic pattern
Time Frame: 3 months
EESG and MESG wave patterns will be used to see if there is a diagnostic pattern that helps identify normal function vs. the motility disorders (achalasia or hypercontractile/spastic disorders)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Dhyanesh Patel, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators agree to the timely release and sharing of information to be no later than the acceptance for publication of the main findings from the final data set. Investigators are also committed to ensuring that all data are free of identifiers that would permit linkage to individual research participants as well as variables that could lead to deductive disclosure of the identity of individual subjects.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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