What this study is
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.
What's being tested
- Clinical measure questionnaires
Intervention · OTHER
Collection of patient reported symptoms and perception of health
- EESG
Intervention · DIAGNOSTIC TEST
Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
- MESG
Intervention · 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)
Intervention · DIAGNOSTIC TEST
Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms
Study details
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Dysphagia
- Enrolling
- 90 people
- Starts
- 2019-09-04
- Est. completion
- 2026-12-30
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University Medical Center
Nashville, Tennessee, United States
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 191280
Principal investigator
Dhyanesh Patel, MD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.