Non-invasive Markers of Esophageal Function in Adults

NCT04074356 | Enrolling By Invitation FDA Device

• 1 other identifier: 191280
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Presence of diagnostic pattern

  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

Study Arms (3)

Healthy Controls

ACTIVE COMPARATOR

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

Other: Clinical measure questionnaires; Diagnostic Test: EESG; Diagnostic Test: MESG

Achalasia subjects

ACTIVE COMPARATOR

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; Diagnostic Test: EESG; Diagnostic Test: MESG; Diagnostic Test: High resolution manometry (HRM)

Hypercontractile/spastic disorder subjects

ACTIVE COMPARATOR

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; Diagnostic Test: EESG; Diagnostic Test: MESG; Diagnostic Test: High resolution manometry (HRM)

Interventions

Clinical measure questionnaires OTHER

Collection of patient reported symptoms and perception of health

Achalasia subjects; Healthy Controls; Hypercontractile/spastic disorder subjects

EESG DIAGNOSTIC_TEST

Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings

Achalasia subjects; Healthy Controls; Hypercontractile/spastic disorder subjects

MESG DIAGNOSTIC_TEST

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

Also known as: SQUID magnetometer

Achalasia subjects; Healthy Controls; Hypercontractile/spastic disorder subjects

High resolution manometry (HRM) DIAGNOSTIC_TEST

Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms

Achalasia subjects; Hypercontractile/spastic disorder subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Dhyanesh Patel, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: September 4, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose

Locations

US (1)