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Esophageal muscle biopsy 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
Study Summary
This trial will study how well a new technology can measure muscle fibrosis in people with achalasia. A better understanding of achalasia will allow intervention at an earlier stage.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,616 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,512 Total Patients Enrolled
Anand Jain, MDPrincipal Investigator - Emory University
Emory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have recently had surgery or a procedure to treat your esophageal motility disorder.You have a heart condition that requires a pacemaker or defibrillator, or your heart rate is either too slow or too fast. You have congestive heart failure with a low ejection fraction, a history of heart attack, or high blood pressure. You also have asthma or chronic obstructive pulmonary disease, trouble emptying your bladder requiring a catheter, narrow-angle glaucoma, or myasthenia gravis. Additionally, your kidney function is below a certain level (GFR <60) for specific parts of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacologic challenge
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with obtaining an esophageal muscle biopsy?
"Thanks to clinical data collected during Phase 4, esophageal muscle biopsy was awarded a score of 3 in terms of safety."
Answered by AI
Could you please provide a list of pertinent investigations that have utilized Esophageal muscle biopsy?
"Currently, 22 active medical trials exploring Esophageal muscle biopsy exist with 6 of them in Phase 3. These studies are largely situated within Shanghai but there is representation from 149 total sites across the globe."
Answered by AI
What is the population size accepted for this research endeavor?
"Affirmative. Based on the information provided by clinicaltrials.gov, this medical trial is seeking 80 participants from a single location and has been open for recruitment since March 17th 2021 with the latest update being posted on March 9th 2022."
Answered by AI
What ailments is an esophageal muscle biopsy typically implemented to diagnose?
"Esophageal muscle biopsy is a frequent treatment for laughing, but can also be quite useful in the management of pupilary conditions, rhinorrhoea, and bile fluid imbalances."
Answered by AI
Are researchers recruiting participants for this study currently?
"Clinicaltrials.gov confirms that the trial is actively enrolling participants, with first posting on March 17th 2021 and most recent edit of March 9th 2022."
Answered by AI
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