New study probes muscle fibrosis in swallowing disorder
NCT ID NCT04641702
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study looks at how muscle scarring in the esophagus relates to swallowing problems in people with achalasia. Researchers will use a special probe and muscle biopsies to measure scarring and muscle function. The goal is to better understand the disease so doctors can treat it earlier.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atropine
- What this could lead to
- If successful, this could lead to earlier diagnosis and better treatments for achalasia by linking muscle scarring to esophageal function.
- What could go wrong
- This is an early-phase observational study with only 80 participants, so results may not apply to all patients. The atropine challenge may cause temporary side effects like dry mouth or blurred vision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2021
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \[exclusions for Aim 1 only\]
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Achalasia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Emory Saint Joseph's Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
-
Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could lying flat vs. on your side change esophageal test results?
- Nerve system glitches may worsen blood pressure swings during achalasia surgery — a study investigates
- New registry tracks POEM procedure for swallowing disorder
- New study investigates why some patients get worse reflux after esophagus surgery
- Small study seeks clues to weight loss mystery in achalasia
- Shingles virus in the gut linked to swallowing disorder – new trial aims to treat it