Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04641702

Comprehensive Esophageal Diagnostics Study

Led by Emory University · Updated on 2025-11-10

80

Participants Needed

2

Research Sites

302 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Comprehensive Esophageal Diagnostics Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Diagnosis of achalasia or esophageal motility disorder confirmed by FLIP or high-resolution esophageal manometry
  • Undergoing diagnostic FLIP study at Emory University Hospital with anesthesia assistance
  • Undergoing Heller myotomy or per-oral endoscopic myotomy for treatment of esophageal motility disorder
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years old
  • Pregnant women
  • Prisoners
  • Non-English speaking
  • Cognitively impaired adults unable to provide informed consent
  • Cardiac disease including arrhythmia requiring ICD or pacemaker, baseline bradycardia with heart rate less than 60 or tachycardia with heart rate greater than 90, congestive heart failure with ejection fraction less than 35%, history of myocardial infarction, baseline mean arterial pressure less than 65 or systolic blood pressure greater than 140
  • Asthma or chronic obstructive pulmonary disease
  • Urinary retention requiring use of foley catheterization
  • Narrow-angle glaucoma
  • Myasthenia gravis
  • Glomerular filtration rate less than 60 (for Aim 1 only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

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Research Team

A

Anand Jain, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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