Measuring esophageal function and swallowing difficulties
Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
Indiana University · NCT04503785
This study is trying to see how two different tests for swallowing problems work in patients with known esophageal issues to better understand their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT04503785 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare esophageal manometry measurements and EndoFLIP Balloon measurements in patients experiencing dysphagia, or difficulty swallowing. It focuses on patients with known esophageal diagnoses who are referred to the GI Motility Lab at Indiana University Hospital. The study seeks to establish a registry that correlates the results of these diagnostic tests with clinical symptoms, enhancing the understanding of non-obstructive dysphagia. Both tests used in this study are FDA-approved and currently utilized in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adults presenting to the GI Motility Lab at Indiana University Hospital for esophageal manometry-impedance and/or EndoFLIP.
Not a fit: Patients under 18 years old or those unable to communicate verbally with staff will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and management of dysphagia, leading to better treatment options for patients.
How similar studies have performed: While the use of manometry and EndoFLIP is established, the correlation between these tests and clinical symptoms in dysphagia has not been clearly defined, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP Exclusion Criteria: * Age \<18 yrs old * Unable to communicate verbally with the staff
Where this trial is running
Indianapolis, Indiana
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: John M Wo, MD — Indiana University
- Study coordinator: Lainna Cohen
- Email: larcohen@iu.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysphagia, Esophageal