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NCT Number: NCT04503785

Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

John Wo, MD

PRINCIPAL_INVESTIGATOR

Lainna Cohen

CONTACT

[email protected]

317-278-0621

Maureen Schilling

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manometry

Diagnostic Test

Transnasal Esophageal manometry and Endoflip Balloon distensibility

Other names: Endoflip

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lainna Cohen

CONTACT

[email protected]

Maureen Schilling

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2020
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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