Non-invasive Esophageal Testing for Swallowing Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Claustrophobia, Metal implants, Morbid obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to study esophageal motility issues using non-invasive tests. It employs two techniques, EESG (a type of non-invasive esophageal testing) and MESG, to measure electrical activity in the esophagus. Researchers are studying individuals with swallowing disorders such as achalasia and hypercontractile or spastic disorders, along with healthy individuals without gastrointestinal issues. The trial suits adults who have undergone standard tests for esophageal motility and have no known gut problems. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve diagnostic methods for esophageal disorders.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking anticoagulants (blood thinners), you will not be able to participate.

What prior data suggests that these non-invasive esophageal testing methods are safe?

Studies have shown that both multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) provide safe and non-invasive ways to test esophageal function. These methods measure electrical and magnetic signals in the esophagus without requiring surgery or inserting anything into the body.

Because EESG and MESG do not involve cutting or entering the body, they are generally easy for people to tolerate. Research has not reported any negative effects from these tests, indicating their safety. Their non-invasive nature means they carry less risk compared to procedures involving direct contact with body tissues.

These methods are similar to other non-invasive tests like electrocardiograms (EKG) for the heart, which are widely used and have a proven safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the non-invasive esophageal testing techniques, EESG and MESG, because they offer a potential game-changer for diagnosing swallowing disorders like achalasia and hypercontractile/spastic disorders. Unlike traditional methods such as high-resolution manometry, which can be uncomfortable and invasive, EESG and MESG use electrical and magnetic signals to assess esophageal function in a much less intrusive way. This could lead to quicker, more comfortable, and perhaps more accurate diagnoses, making the patient's experience significantly better.

What evidence suggests that EESG and MESG are effective for swallowing disorders?

This trial will evaluate the use of electroesophagogram (EESG) and magnetoesophagogram (MESG) in diagnosing swallowing disorders. Participants with achalasia or hypercontractile/spastic disorders, along with healthy controls, will undergo testing with both EESG and MESG. Studies have shown that EESG helps understand esophageal movement issues in conditions like achalasia and hypercontractile disorders. Research indicates that these tests can complement standard assessments, offering a more complete picture of esophageal behavior. MESG is still under study, and data on its effectiveness for these conditions remains limited. Like EESG, MESG aims to assess esophageal movement non-invasively. Early findings suggest it could provide useful insights, but further research is needed to confirm its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Dhyanesh Patel, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with no gastrointestinal issues, or those getting routine checks for esophageal motility. It's not for people with MRI contraindications like pacemakers, severe obesity, heart rhythm problems, anticoagulant use, or claustrophobia.

Inclusion Criteria

I am 18 or older and getting an HRM test for esophagus issues.

I am over 18 and do not have any known stomach or intestine problems.

Exclusion Criteria

You are extremely overweight and may not fit comfortably under the SQUID device being used in the study.

I do not have a history of heart rhythm problems nor am I on blood thinners.

You are afraid of being in small spaces and cannot stay still during the required test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo EESG and MESG testing to assess esophageal function and motility disorders

3 months

Multiple visits for testing

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EESG
• High resolution manometry (HRM)
• MESG

Trial Overview The study tests noninvasive methods to record esophageal activity in adults using EESG and MESG alongside High resolution manometry (HRM), which are techniques to measure muscle function and movements of the esophagus.

How Is the Trial Designed?

Group I: Achalasia subjects Active Control 4 Interventions

Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of achalasia will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Group II: Hypercontractile/spastic disorder subjects Active Control 4 Interventions

Subjects who have undergone standard of care high resolution manometry that results in a diagnosis of hypercontractile/spastic disorder will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Group III: Healthy Controls Active Control 3 Interventions

Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3618975/

Management of Spastic Disorders of the Esophagus - PMC In total, 13 of the 14 patients had LES dysfunction evident either on barium swallow or manometry, suggesting that the 2 techniques were complementary in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1521691824000313

POEM for non-achalasia spastic oesophageal motility ... The study reported a success rate of 58.3%, comparable to that observed in achalasia patients. Notably, symptom relief was more sustained in OGJOO patients when ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922458/

Presence of esophageal contractility after achalasia ... In a study of 122 achalasia patients, we found post-treatment contractile activity in 50% cases, facilitated when adequate EGJ opening was achieved.

4. jnmjournal.org jnmjournal.org/journal/view.html?uid=1838&vmd=Full

Hypercontractile Esophagus: Clinical and Manometric ... This study aims to investigate the clinical and manometric features of HE and evaluate treatment outcomes in a multicenter Korean cohort.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.13594

Hypercontractile esophageal motility disorder or functional ... The surprising outcome of the study was that both active botulinum toxin treatment and sham treatment resulted in a significant reduction in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9021980/

Use and Safety of Per-Oral Endoscopic Myotomy for Achalasia ... This cohort study investigates the use, safety, and costs associated with the use of per-oral endoscopic myotomy for achalasia in the US.

7. gastroenterologyadvisor.com gastroenterologyadvisor.com/news/in-older-patients-with-achalasia-minimally-invasive-poem-is-very-successful/

In Older Patients With Achalasia, Minimally Invasive POEM ... In older patients with achalasia, peroral endoscopic myotomy was safe and effective, with success rates comparable to those in younger ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510721013481

Peroral endoscopic myotomy: 10-year outcomes from a ... POEM is exceptionally safe and highly effective on long-term follow-up, with >90% clinical success at ≥5 years.

9. researchgate.net researchgate.net/publication/229433709_Progression_of_diffuse_esophageal_spasm_to_achalasia_Incidence_and_predictive_factors

Progression of diffuse esophageal spasm to achalasia One study performed during the era of conventional manometry found that DES progresses to achalasia in 8% (1/12) of patients after a mean follow ...

10. bestpractice.bmj.com bestpractice.bmj.com/topics/en-us/872

Achalasia - Symptoms, diagnosis and treatment Achalasia is an esophageal motor disorder characterized by a loss of esophageal peristalsis and failure of the lower esophageal sphincter to relax in response ...