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NCT06883175 · ClinicalTrials.gov registry record · NA
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
A NA study of Dysphagia and Achalasia, Esophageal, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 575
- Enrollment target
- 1
- Study location
NCT06883175 is a NA study of Dysphagia and Achalasia, Esophageal that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 575 participants, above the 156-participant average among 35 other Dysphagia trials with a reported enrollment target (269% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06883175, a NA study of Dysphagia and Achalasia, Esophageal, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 575 participants
- Enrollment target
- 1
- Study location
Study Summary
Swallowing difficulties are extremely common and result in substantial morbidity, reduction in the quality of life, and mortality related to malnutrition and complications from regurgitation and aspiration. Unfortunately, our understanding regarding the pathophysiology of dysphagia and GERD has been hampered by focusing predominantly on circular muscle activity and ignoring the essential biomechanical properties of the esophageal wall that promote normal emptying. Our initial work explored the relationship between intrabolus pressure (IBP) and esophagogastric junction (EGJ) compliance as a metric for outflow resistance. This work highlighted the direct relationship between IBP and EGJ opening and was the foundation for the development of the classification scheme utilized around the world to diagnose esophageal motor disorders: "the Chicago Classification" (CC). Despite this improved understanding focused on bolus transit dynamics, there are still significant gaps in our scientific understanding centered on the lack of a true correlate for symptoms, reliable predictive models and effective treatments for Functional dysphagia, IEM and EGJOO. Given these limitations, we have developed novel approaches that combine assessments of primary and secondary peristalsis (a NeuroMyogenic Model of esophageal function). These will leverage our recent findings supporting the importance of the esophageal response to distension in bolus clearance, noting that this response of the esophageal wall to bolus retention or reflux is one of the most essential functions of the esophagus in preventing complications of aspiration, or reflux injury. We will also include an assessment of esophageal geometry and wall biomechanics (elasticity/dilatation) as these carry essential interactions with esophageal function that are overlooked in the current diagnostic paradigms. In order to test our hypothesis that wall mechanics are a major determinant of esophageal diseases, we had to develop new ap
Conditions Studied
Interventions
- DIAGNOSTIC_TEST FLIP
- DIAGNOSTIC_TEST HRM
- OTHER Prucalopride
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2029-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06883175
The ClinicalTrials.gov registry entry for NCT06883175 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 156-participant average among 35 other Dysphagia trials with a reported enrollment target (269% higher). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Dysphagia appearing as the primary indexed condition, and to 3 interventions - of which FLIP is the first listed.
NCT06883175 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06883175 about?
NCT06883175 is a clinical study titled "Evolution of the Chicago Classification: Bridging Physiology and Mechanics". Swallowing difficulties are extremely common and result in substantial morbidity, reduction in the quality of life, and mortality related to malnutrition and complications from regurgitation and aspiration. Unfortunately, our understanding regarding the pathophysiology of dysphagia and GERD has been...
What is the current status of trial NCT06883175?
This trial is currently recruiting. It is a NA study. The enrollment target is 575 participants. The study started on 2024-09-01. Estimated completion is 2029-06-30.
What conditions does trial NCT06883175 study?
This clinical trial studies the following conditions: Dysphagia, Achalasia, Esophageal, Ineffective Esophageal Motility.
What interventions are being tested in trial NCT06883175?
The interventions under investigation include: FLIP (DIAGNOSTIC_TEST), HRM (DIAGNOSTIC_TEST), Prucalopride (OTHER).
Who is sponsoring clinical trial NCT06883175?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06883175 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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