A Phase 4 interventional study of Atropine challenge and Esophageal muscle biopsy in Achalasia, sponsored by Emory University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Emory University · Phase 4, Interventional, and Basic science
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Among 52 studies in Esophageal Achalasia with a site in United States — 18 open to participants now, 18 under way, 2 of them phase 3. Esophageal Achalasia · United States.
Among the 52 studies in Esophageal Achalasia with a site in United States, this one is the 14th largest by planned enrollment of the 33 interventional ones that give a count, is one of 5 that started in 2021, is one of 4 in phase 4, reaches primary completion later than 10 of the 17 other live ones, and was the 35th registered.
143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
Browse Esophageal Achalasia studies →18 of the 52 studies in Esophageal Achalasia with a site in United States are open now. Recruiting first, the newest first:
Northwestern University · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 5–21
Northwestern University · Sites in United States
Ages 18+
Baylor College of Medicine · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 31 Esophageal Achalasia studies recruiting now, 20 (65%) set no upper age limit and 5 (16%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 2 · Phase 4 4
First in 1999; this study’s year is marked. 5 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 56 across 95 interventional studies indexed under Esophageal Achalasia.
Median enrollment 42 across the 33 interventional studies, 200 across the 19 observational. Of the 26 that completed or were terminated, 1 (4%) have results posted.
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1 of 52 have an industry lead sponsor. The 10 most frequent:
Emory University is the lead sponsor of 1,405 studies on the registry; 223 are open to participants now.
Of its 238 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Emory University has 1 study filed under Esophageal Achalasia — fewer than ten, so there is no comparison to draw.
4 of the studies in Esophageal Achalasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04640753Methodist Health SystemPeroral Endoscopic Myotomy for the Treatment of Achalasia | 2027-02-05 |
| NCT07780981Johns Hopkins UniversityImpact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions | 2027-07-01 |
| NCT07496840Baylor College of MedicineClinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM) | 2027-07-30 |
| NCT05550194Vanderbilt University Medical CenterVZV in the Enteric Nervous System: Pathogenesis and Consequences | 2027-08 |
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Among the 52 studies in Esophageal Achalasia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Achalasia is a disease characterized by inadequate opening of the lower esophageal sphincter. Achalasia is presumed to be due to neuronal dysfunction (active), however there are other variables such as muscle layer fibrosis (passive) that may contribute, particularly in milder or earlier achalasia variants. A new technology, impedance planimetry, may be able to measure active vs passive features of the lower esophageal sphincter (LES).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)
Drug: Atropine challenge
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.
Procedure: Esophageal muscle biopsy
Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments.
Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.
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.
Degree of lower esophageal sphincter contraction and relaxation
Degree of lower esophageal sphincter contraction and relaxation will be measured
Time frame: Two minutes after the study drugs administration
The collagen content in muscle biopsy specimens
The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining.
Time frame: Two minutes after the study drugs administration
Plan to share: Yes — Esophageal function testing data, symptom questionnaire data, treatments performed, and biospecimen analysis results will be shared.
Supporting information: Study protocol, Statistical analysis plan
Access criteria: Collaborators with whom the study team has Data Use Agreements in Place will have access through secure electronic means.
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Dec 2028, 93 months after the start.
How these figures are worked out, and which studies are left out of them.
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