Status:
RECRUITING
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
The California Medical Innovations Institute, Inc.
Conditions:
Dysphagia
Achalasia, Esophageal
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 aspir...
Detailed Description
The proposed experiments in this application will utilize both standard of care diagnostic testing and treatment as well as research procedures in small subsets of participants as required for each Sp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT06883175
Start Date
September 1 2024
End Date
June 30 2029
Last Update
August 11 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611