- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503785
Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia, difficulty swallowing, is one of the most common issues in gastroenterology. In many patients, esophageal obstruction is not identified despite workup with upper endoscopy or barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently being used in clinical practice. However, correlation of the results obtained from these tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the relationship between esophageal impedance-manometry and EndoFLIP results has never been defined.
The primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Basil Kahwash, MD
- Email: bkahwash@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dysphagia
Patients with Esophageal dysphagia
|
Transnasal Esophageal manometry and Endoflip Balloon distensibility
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endoflip parameters for gastroparesis
Time Frame: 5 years
|
Compare the distensibility index (mm2/mmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between endoflip parameters and gastric scintigraphy
Time Frame: 5 years
|
Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis
|
5 years
|
Correlation between endoflip parameters and symptom severity
Time Frame: 5 years
|
Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John M Wo, MD, Indiana University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1701721848
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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