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Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04503785
Enrollment
1000
Registered
2020-08-07
Start date
2017-01-17
Completion date
2025-12-31
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Esophageal

Brief summary

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_TESTManometry

Transnasal Esophageal manometry and Endoflip Balloon distensibility

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Endoflip parameters for gastroparesis5 yearsCompare 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.

Secondary

MeasureTime frameDescription
Correlation between endoflip parameters and gastric scintigraphy5 yearsCorrelate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis
Correlation between endoflip parameters and symptom severity5 yearsCorrelate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)

Countries

United States

Contacts

Primary ContactLainna Cohen
larcohen@iu.edu
Backup ContactMaureen Schilling
maschi@iu.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026