Recruiting
Phase 4

Observational Study

Sponsor:

Emory University

Code:

NCT04641702

Conditions

Achalasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atropine challenge

Esophageal muscle biopsy

Study Details

Brief 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.

Conditions

Achalasia

Study ID

NCT04641702

Start date

Mar 17, 2021

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 <60 or tachycardia with a heart rate (HR) > 90, congestive heart failure with ejection fraction <35%, history of myocardial infarction, baseline mean arterial pressure (MAP) <65 or systolic blood pressure (BP) >140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, glomerular filtration rate (GFR) <60 \[exclusions for Aim 1 only\]

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pharmacologic challenge

Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)

other: Esophageal muscle biopsy

Patients with a diagnosis of an esophageal motility disorder who are undergoing Heller myotomy, per-oral endoscopic myotomy, or esophagectomy for treatment of their esophageal motility disorder.

no intervention: Normal esophageal tissues

Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments.

Interventions

Atropine challenge

Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.

Esophageal muscle biopsy

During standard-of-care Heller myotomy, per-oral endoscopic myotomy, or esophagectomy, lower esophageal sphincter and distal esophageal circular muscle samples will be taken with biopsy forceps. 2-3 samples, approximately 2-3 mm each, will be collected.

Primary outcome measure

  • Degree of lower esophageal sphincter contraction and relaxation [ Time Frame: Two minutes after the study drugs administration ]
  • The collagen content in muscle biopsy specimens [ Time Frame: Two minutes after the study drugs administration ]

Central Contacts and Locations

Central contacts

Anand Jain, MD

404-778-3184anand.jain@emory.edu

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

More Information

Sponsor

Emory University

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • lower esophageal sphincter
  • Functional Lumen Imaging Probe Topography
  • anti-fibrosis agents
  • anti-inflammatory agents

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Emory University on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.