Esophageal muscle biopsy for Achalasia

Emory University Hospital, Atlanta, GA

Esophageal muscle biopsy +1 morePhase 4RecruitingLed by Anand Jain, MDResearch Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Undergoing Heller myotomy or per oral endoscopic myotomy for treatment of their esophageal motility disorder (for Aim 2)

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow upstwo minutes after the study drugs administration

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

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.

Eligible Conditions

Achalasia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have recently had surgery or a procedure to treat your esophageal motility disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow ups ~ two minutes after the study drugs administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow ups ~ 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

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

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

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

Drug Has Already Been Approved

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pharmacologic challengeExperimental Treatment2 Interventions

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

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,574 Previous Clinical Trials

2,879,649 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,244 Previous Clinical Trials

4,198,781 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

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

Recent research and studies

clinicaltrials.govStudy

Comprehensive Esophageal Diagnostics Study

Anand Jain 2021. "Comprehensive Esophageal Diagnostics Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04641702.