← Back to Search

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

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 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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pharmacologic challengeExperimental Treatment2 Interventions
Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)

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.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,688 Previous Clinical Trials
2,602,835 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,428 Previous Clinical Trials
4,322,850 Total Patients Enrolled
Anand Jain, MDPrincipal Investigator - Emory University
Emory University

Media Library

Esophageal muscle biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04641702 — Phase 4
Achalasia Research Study Groups: Pharmacologic challenge
Achalasia Clinical Trial 2023: Esophageal muscle biopsy Highlights & Side Effects. Trial Name: NCT04641702 — Phase 4
Esophageal muscle biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641702 — Phase 4
~17 spots leftby Oct 2025