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Recruiting
NCT04641702
Comprehensive Esophageal Diagnostics Study
Conditions: Achalasia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Emory University
Location: Emory University Hospital Atlanta Georgia
Summary
The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.
Eligibility Criteria
Inclusion Criteria:
* Male or female patients, age 18 and above.
* Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020.
* Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)
* Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)
* Undergoing Heller myotomy or per-oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)
* 8 healthy control esophageal samples will be obtained from the NDRI donor program for Aim 2.
Exclusion Criteria:
* Patients younger than 18 years old
* Pregnant women
* Prisoners
* Non-English-speaking patients - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) questionnaires written in English with some medical terms. These are standardized questionnaires with no short forms available.
* Cognitively impaired adults unable to provide informed consent
* Cardiac disease in the form of - arrhythmia requiring intracardiac defibrillator (ICD) or pacemaker, baseline bradycardia with HR \ 90, congestive heart failure with ejection fraction \
Source: ClinicalTrials.gov (NCT04641702). StuddyBuddy aggregates publicly available trial information.