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Procedure
HRM, FLIP, and Prucalopride for Dysphagia
Chicago, IL
N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female subjects aged 18-85 years old inclusive
Mentally capable to provide informed consent
Must not have
Long-segment Barrett's metaplasia
Evidence of mechanical obstruction due to stricture (e.g., peptic/GERD patients, EoE, or other) or previous small bowel or colonic obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to better understand swallowing difficulties by focusing on the mechanics of the esophageal wall and its role in normal swallowing. The researchers have developed new techniques to measure pressure and diameter changes in the
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Who is the study for?
This trial is for individuals experiencing swallowing difficulties, including those with primary achalasia or other related conditions. Participants should have symptoms that align with the study's focus on esophageal motor disorders and be willing to undergo novel diagnostic assessments.Check my eligibility
What is being tested?
The trial is testing new approaches like HRM (High-Resolution Manometry), FLIP (Functional Luminal Imaging Probe), and Prucalopride to measure esophageal mechanics and function. It aims to improve diagnosis by combining these techniques with traditional methods.See study design
What are the potential side effects?
Potential side effects may include discomfort from the procedures, such as sore throat from manometry, bloating or pain during FLIP assessment, and gastrointestinal symptoms like nausea or diarrhea from Prucalopride.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
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I am mentally able to understand and agree to the study's procedures.
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I am experiencing swallowing difficulties, chest pain, or food getting stuck.
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I can undergo endoscopy and related tests for my condition.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long area of Barrett's esophagus.
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I have had blockages in my digestive tract due to narrowing or previous obstructions.
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I do not have any brain or thinking problems that would stop me from joining a study.
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I do not have severe mental illness like uncontrolled depression, active psychosis, or schizophrenia.
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I cannot stop my blood thinners for a procedure.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brief Esophageal Dysphagia Questionnaire (BEDQ)
Esophageal Clearance
Esophagogastric Junction (EGJ) diameter
+4 moreSecondary study objectives
Bolus Retention
Eckhart Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dysphagia participantsExperimental Treatment3 Interventions
There are no arms in this study. All subjects will be studied in like manner.
Find a Location
Closest Location:Northwestern University· Chicago, IL
Who is running the clinical trial?
The California Medical Innovations Institute, Inc.OTHER
3 Previous Clinical Trials
214 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,672 Previous Clinical Trials
987,967 Total Patients Enrolled