Menu
Recruiting NCT04503785

Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Observational Dysphagia, Esophageal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manometry.
Who it may be relevant to
Registry conditions: Dysphagia, Esophageal. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis

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

Interventions

  • Diagnostic test Manometry
    Transnasal Esophageal manometry and Endoflip Balloon distensibility

Primary outcome measures

  • Endoflip parameters for gastroparesis [Time frame: 5 years]
Secondary outcome measures (2)
  • Correlation between endoflip parameters and gastric scintigraphy [Time frame: 5 years]
  • Correlation between endoflip parameters and symptom severity [Time frame: 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Indiana University Health University Hospital — Indianapolis

Identifiers

NCT: NCT04503785 · 1701721848

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗