AchalasiaPhase 4NCT04641702
Comprehensive Esophageal Diagnostics Study
A Phase 4 study testing Atropine challenge and Esophageal muscle biopsy in people with Achalasia, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- Atropine challenge and Esophageal muscle biopsy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2021to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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]
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders
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.
Read the detailed description
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.
- Conditions
- Achalasia
- Being tested
- Atropine challenge, Esophageal muscle biopsy
- Keywords
- lower esophageal sphincter, Functional Lumen Imaging Probe Topography, anti-fibrosis agents, anti-inflammatory agents
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine challengeDrug
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 biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacologic challenge | Experimental | Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP) Receives: Drug: Atropine challenge |
| Esophageal muscle biopsy | Other | 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. Receives: Procedure: Esophageal muscle biopsy |
| Normal esophageal tissues | No intervention | Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of lower esophageal sphincter contraction and relaxation
Degree of lower esophageal sphincter contraction and relaxation will be measured
Measured: 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.
Measured: Two minutes after the study drugs administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start17 Mar 2021
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants may consent to Aim 1(pharmacologic challenge), Aim 2 (if they undergo a future myotomy), or both aims. After completion of Aim 1 enrollment, participants who are scheduled to undergo Heller myotomy, per-oral endoscopic myotomy (POEM), or esophagectomy for treatment of their esophageal motility disorder may participate in Aim 2 only.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Jain, Emory University
- Investigators
- Anand Jain, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641702
- Sponsor's protocol ID
- STUDY00001665
- Other IDs
- 1K23DK131317-01A1, R03DK145962, 2025P013181
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Esophageal function testing data, symptom questionnaire data, treatments performed, and biospecimen analysis results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders
- ClinicalTrials.gov ID
- NCT04641702
- Acronym / sponsor ID
- STUDY00001665
- Conditions
- Achalasia
- Keywords
- lower esophageal sphincter, Functional Lumen Imaging Probe Topography, anti-fibrosis agents, anti-inflammatory agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants may consent to Aim 1(pharmacologic challenge), Aim 2 (if they undergo a future myotomy), or both aims. After completion of Aim 1 enrollment, participants who are scheduled to undergo Heller myotomy, per-oral endoscopic myotomy (POEM), or esophagectomy for treatment of their esophageal motility disorder may participate in Aim 2 only.
| Arm | Type | Receives |
|---|---|---|
| Pharmacologic challenge | Experimental | Drug: Atropine challengeMeasurement of esophageal response to atropine using functional lumen imaging probe (FLIP) |
| Esophageal muscle biopsy | Other | Procedure: Esophageal muscle biopsyPatients 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. |
| Normal esophageal tissues | No intervention | –Normal esophageal tissues will be obtained from the National Disease Research Interchange (NDRI) donor program to perform muscle biopsy experiments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine challengeAtropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated. | Drug | Pharmacologic challenge |
| Esophageal muscle biopsyDuring 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. | Procedure or surgery | Esophageal muscle biopsy |
Primary outcome
Degree of lower esophageal sphincter contraction and relaxation
Time frame: Two minutes after the study drugs administration
Degree of lower esophageal sphincter contraction and relaxation will be measured
The collagen content in muscle biopsy specimens
Time frame: Two minutes after the study drugs administration
The collagen content in muscle biopsy specimens will be measured on Sirius Red and Masson Trichrome staining.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. Esophageal function testing data, symptom questionnaire data, treatments performed, and biospecimen analysis results will be shared.
Related trials for Achalasia
RecruitingPhase 2
Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
Achalasia Cardia, Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingPhase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Achalasia
Recruiting
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Dysphagia, Achalasia, Esophageal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anand Jain, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine challenge and Esophageal muscle biopsy in people with Achalasia, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anand Jain, MD (404-778-3184, anand.jain@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of lower esophageal sphincter contraction and relaxation (time frame: Two minutes after the study drugs administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.