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Non-invasive Esophageal Testing for Swallowing Disorders

N/A
Waitlist Available
Led By Dhyanesh Patel, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥ 18 years of age who are undergoing HRM for routine standard of care evaluation for esophageal motility.
Normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study a new way to measure electrical activity in the esophagus to understand how it works and if it is a noninvasive option.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring techniques rather than medication or invasive procedures, significant side effects are not expected. However, discomfort from lying still during measurements may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and getting an HRM test for esophagus issues.
Select...
I am over 18 and do not have any known stomach or intestine problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Presence of diagnostic pattern

Trial Design

3Treatment groups
Active Control
Group I: Achalasia subjectsActive Control4 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 subjectsActive Control4 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 ControlsActive Control3 Interventions
Healthy volunteers with no known gastrointestinal complications will be given questionnaires and testing by electroesophagogram (EESG) and magnetoesophagogram (MESG).

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,102 Total Patients Enrolled
Dhyanesh Patel, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
83 Total Patients Enrolled

Media Library

EESG Clinical Trial Eligibility Overview. Trial Name: NCT04074356 — N/A
Swallowing Difficulty Research Study Groups: Achalasia subjects, Hypercontractile/spastic disorder subjects, Healthy Controls
Swallowing Difficulty Clinical Trial 2023: EESG Highlights & Side Effects. Trial Name: NCT04074356 — N/A
EESG 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074356 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently open for the current clinical trial?

"The information from clinicaltrials.gov indicates that this trial is not presently searching for subjects; the initial posting was made on September 4th 2019 and it last updated August 4th 2022. Despite its inactivity, 73 other studies are actively recruiting patients right now."

Answered by AI
~6 spots leftby Sep 2024