What is the mechanism of action of this treatment?

Achalasia treatments primarily aim to reduce the pressure of the lower esophageal sphincter (LES) to facilitate the passage of food and liquids. Common treatments include pneumatic dilation, laparoscopic Heller myotomy, and peroral endoscopic myotomy (POEM), which mechanically disrupt the LES muscle. Pharmacologic treatments, such as botulinum toxin injections, temporarily paralyze the LES muscle. Understanding LES function and muscle fibrosis using FLIP Topography, as studied in the trial, is essential for assessing treatment effectiveness and personalizing therapy for achalasia patients.

What side effects are associated with this type of intervention?

Common treatments for Achalasia, such as peroral endoscopic myotomy (POEM) and pneumatic dilation, have specific side effects. POEM is generally associated with a high success rate but can lead to adverse events such as mild to moderate perforations and bleeding, which are usually manageable. Pneumatic dilation, another common treatment, can result in esophageal perforation, chest pain, and gastroesophageal reflux. Both treatments aim to improve esophageal function but carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Achalasia, focusing primarily on interventions that improve the function of the lower esophageal sphincter (LES). These include pneumatic dilation, botulinum toxin injections, and surgical myotomy, such as Heller myotomy. More recently, peroral endoscopic myotomy (POEM) has gained attention for its efficacy and minimally invasive nature. While specific pharmacologic agents targeting LES function and muscle fibrosis are still under investigation, these treatments aim to reduce LES pressure and improve esophageal emptying, aligning with the goals of studies utilizing FLIP Topography to assess LES function.

What other types of research exist?

Promising novel alternatives for achalasia patients considering treatment in 2024 include Peroral Endoscopic Myotomy (POEM) and Endoscopic Pyloromyotomy (G-POEM). These minimally invasive procedures have shown comparable efficacy to traditional surgical methods with lower complication rates and shorter hospital stays. Additionally, advancements in endoscopic techniques and the use of transpyloric stents have also been evaluated for their effectiveness in treating related esophageal motility disorders.

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Diagnostic Methods for Achalasia

Phase 4

Recruiting

Led By Anand Jain, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two minutes after the study drugs administration

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial uses a new technology to map the lower esophageal sphincter in patients with achalasia. It helps doctors understand if the problem is due to muscle stiffness or nerve issues, allowing for earlier and better treatment. EsoFLIP is a new technology used for esophageal dilation in achalasia.

Who is the study for?

Adults over 18 with achalasia or esophageal motility disorders, who are undergoing specific treatments like Heller myotomy or per oral endoscopic myotomy. They must have been evaluated at Emory facilities and not be pregnant, imprisoned, cognitively impaired without consent ability, have severe cardiac issues, respiratory diseases, urinary retention problems, glaucoma, myasthenia gravis or poor kidney function.

What is being tested?

The trial is testing how muscle fibrosis relates to lower esophageal sphincter measurements using a new technology called FLIP Topography after an atropine challenge. It aims to improve early intervention in achalasia by understanding the condition better through these tests and biopsies.

What are the potential side effects?

Potential side effects may include reactions to the atropine challenge such as dry mouth, blurred vision, sensitivity to light, lack of sweating and increased heart rate. The biopsy procedure might cause discomfort or minor bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two minutes after the study drugs administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two minutes after the study drugs administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and two minutes after the study drugs administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Degree of lower esophageal sphincter contraction and relaxation

The collagen content in muscle biopsy specimens

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pharmacologic challengeExperimental Treatment2 Interventions

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Achalasia treatments primarily aim to reduce the pressure of the lower esophageal sphincter (LES) to facilitate the passage of food and liquids. Common treatments include pneumatic dilation, laparoscopic Heller myotomy, and peroral endoscopic myotomy (POEM), which mechanically disrupt the LES muscle. Pharmacologic treatments, such as botulinum toxin injections, temporarily paralyze the LES muscle. Understanding LES function and muscle fibrosis using FLIP Topography, as studied in the trial, is essential for assessing treatment effectiveness and personalizing therapy for achalasia patients.