Non-invasive Markers of Esophageal Function in Adults

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT04074356
Status
Enrolling By Invitation

Conditions

  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clinical measure questionnaires — OTHER
    Collection of patient reported symptoms and perception of health
  • EESG — DIAGNOSTIC_TEST
    Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
  • 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
  • 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

Study Details

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.

Key Dates

Start date
Sep 4, 2019
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Presence of diagnostic pattern [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

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By research site
Vanderbilt University Medical Center· Nashville, TN

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