Evolution of the Chicago Classification: Bridging Physiology and Mechanics

Launched by NORTHWESTERN UNIVERSITY · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding and improving the way we diagnose and treat swallowing difficulties, a condition known as dysphagia. Many people experience dysphagia, which can lead to serious health issues like malnutrition or complications from food going down the wrong way. The researchers are looking to develop new methods to measure how the esophagus (the tube that carries food from the mouth to the stomach) works, particularly how it responds to swallowing and the pressure of food as it moves through. By creating better tools to assess these functions, the trial aims to find more effective treatments for conditions like achalasia and gastroesophageal reflux disease (GERD).

To participate in this trial, individuals aged 18 to 85 who have symptoms such as difficulty swallowing, regurgitation, or chest pain may be eligible. Candidates must be able to undergo specific tests that help evaluate esophageal function. Participants can expect to take part in assessments using new technologies that measure how the esophagus responds during swallowing, providing valuable information that could lead to improved treatment options. It's important to note that certain health conditions, such as severe esophagitis or mechanical obstructions, may exclude individuals from participating. If you or someone you know struggles with swallowing issues, this trial may offer a chance to contribute to advancements in understanding and treating these conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The source of the study population will be male and female subjects aged 18-85 years old inclusive (females of childbearing potential should be on highly effective contraceptive methods) and mentally capable to provide informed consent who present to the Northwestern Medicine Digestive Health Center with the chief complaint of dysphagia, regurgitation, chest pain or food impaction, or referral for treatment of achalasia, GERD, scleroderma, or endoscopy negative dysphagia. All subjects must be able to undergo endoscopy with functional lumen imaging probe (FLIP) and transnasal intubation for 4 dimensional-High Resolution Manometry (4D HRM) and 24-hour pH impedance probe.
• Exclusion Criteria:
• • Currently participating in a concurrent clinical trial or completed another trial within past 8 weeks.
• • Active severe esophagitis (Los Angeles esophagitis Grade C and above), Patients may be eligible once esophagitis is healed if they continue to have dysphagia in the context of healed esophagitis.
• • Contact PD/PI: Pandolfino, John Erik Protection of Human Subjects Page 131
• • Evidence of mechanical obstruction due to stricture (e.g., peptic/GERD patients, EoE, or other) or previous small bowel or colonic obstruction.
• • Long-segment Barrett's metaplasia.
• • Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. EKG will be performed before prucalopride in the 60 patients undergoing Experiment 1a.
• • Current drug or alcohol abuse or dependency.
• • Current neurologic or cognitive impairment which would make the patient an unsuitable candidate for a research trial.
• • Severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder.
• • Pregnant patients.
• • Bleeding diathesis or need for anticoagulation that cannot be stopped for endoscopy.