HRM, FLIP, and Prucalopride for Dysphagia

Overseen By Dustin A Carlson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Anticoagulants

Disqualifiers: Severe esophagitis, Barrett's metaplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

575 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods for understanding and treating swallowing difficulties (dysphagia) by examining esophageal movement and response to food. Researchers will employ advanced technology, including FLIP (Functional Lumen Imaging Probe) and HRM (High-Resolution Manometry), to study the esophagus's structure and movement, with the goal of finding better ways to predict and treat this condition. Individuals who frequently experience difficulty swallowing, chest pain, or food impaction may be suitable candidates for this trial. Participants will undergo specific procedures to assess their esophageal function. The ultimate goal is to enhance treatments for conditions like functional dysphagia and GERD (gastroesophageal reflux disease).

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for swallowing difficulties.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these techniques are safe for studying dysphagia?

Studies have shown that the Functional Lumen Imaging Probe (FLIP) is a safe tool for diagnosing swallowing problems. It measures the size and pressure in the esophagus in real time. FLIP is often used during procedures with sedation and performs well even with common sedatives. This capability allows doctors to make quick decisions safely without extra risks.

High-Resolution Manometry (HRM) is also safe and generally easy to handle. Most people experience no trouble with it. Only about 1 in 100 patients find it difficult, with this being more common in children. For adults with swallowing issues, HRM provides a reliable way to assess esophageal function, aiding doctors in understanding and treating these problems more effectively.

For those considering participation in a trial using these tools, research suggests that both FLIP and HRM are safe options for examining swallowing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for dysphagia because it explores the use of high-resolution manometry (HRM) and functional lumen imaging probe (FLIP) as diagnostic tools, alongside the use of prucalopride. Unlike traditional treatments that focus mainly on swallowing exercises or dietary changes, HRM and FLIP provide a detailed look at the muscle function and structure of the esophagus, potentially leading to more precise diagnoses. Prucalopride, a prokinetic agent, could improve esophageal motility by enhancing bowel movements, which is different from standard treatments. This combination of advanced diagnostic techniques and a novel therapeutic approach could pave the way for more effective management of dysphagia.

What evidence suggests that FLIP and HRM could be effective for dysphagia?

Research has shown that both FLIP (Functional Lumen Imaging Probe) and HRM (High-Resolution Manometry) are promising tools for understanding and addressing swallowing difficulties, known as dysphagia. Studies indicate that FLIP effectively measures the size and pressure of the esophagus, helping to identify issues when other tests are unclear. In a study of 175 patients, certain FLIP measurements linked to symptoms of dysphagia. Meanwhile, HRM detected major movement problems in the esophagus in about 70% of patients with swallowing difficulties. These techniques are crucial for diagnosing and understanding dysphagia and could lead to better treatment options.

In this trial, researchers will study all participants using both FLIP and HRM to further explore their effectiveness in diagnosing and understanding dysphagia. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am using a reliable method of birth control.

I am mentally able to understand and agree to the study's procedures.

I am experiencing swallowing difficulties, chest pain, or food getting stuck.

Exclusion Criteria

Currently participating in a concurrent clinical trial or completed another trial within the past 8 weeks

Pregnant patients

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo various diagnostic and treatment procedures including prucalopride treatment, FLIP with manometry, and esophagram evaluation

2 weeks

Multiple visits for procedures and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of esophageal clearance and recoil

6 months

Follow-up assessments at 6 months post-treatment

Extension

Participants may undergo additional procedures if initial treatment targets are not met, such as repeat POEM

As needed based on treatment response

What Are the Treatments Tested in This Trial?

Interventions

• FLIP
• HRM

Trial Overview 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.

How Is the Trial Designed?

Group I: Dysphagia participants Experimental Treatment 3 Interventions

There are no arms in this study. All subjects will be studied in like manner.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

The California Medical Innovations Institute, Inc.

Collaborator

Trials

4

Recruited

790+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9380028/

Use of the Functional Lumen Imaging Probe in Clinical ... In a series of 175 patients, final intraoperative EGJ-DI <2 mm Hg/mm2 was associated with dysphagia and gas bloat more often, whereas values 2–3.5 mm Hg/mm2 ...

2. gastrojournal.org gastrojournal.org/article/S0016-5085(25)00773-5/fulltext

AGA Clinical Practice Update on Incorporating Functional ... The functional lumen imaging probe (FLIP) is a useful diagnostic tool that measures esophageal dimensions and pressures in real time.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508525007735

AGA Clinical Practice Update on Incorporating Functional ... To summarize the available evidence and offer expert best practice advice on the incorporation of the functional lumen imaging probe (FLIP) into clinical ...

4. giejournal.org giejournal.org/article/S0016-5107(23)01880-1/pdf

EVALUATION OF FUNCTIONAL LUMEN IMAGING PROBE ... Discussion: Our study confirms that approximately 50% of patients with persistent dysphagia and indeterminate HRM will have significant pathologic findings on ...

5. jnmjournal.org jnmjournal.org/journal/view.html?uid=1978&vmd=Full&

When Manometry and Functional Lumen Imaging Probe ... Large-scale investigations comparing HRM, FLIP, and TBE outcomes in well-defined dysphagia populations are paramount to refine diagnostic algorithms. Ultimately ...

6. gastro.org gastro.org/news/best-practices-for-incorporating-flip-into-clinical-practice/

Best practices for incorporating FLIP into clinical practice It is safe, unaffected by commonly used sedatives, and enables clinicians to make immediate decisions at the point of care. AGA's new clinical ...

7. uptodate.com uptodate.com/contents/functional-lumen-imaging-probe-flip-for-adults-with-esophageal-disorders

Functional lumen imaging probe (FLIP) for adults with ... ... dysphagia in ... This review will discuss the technical aspects, data acquisition, and data analysis of FLIP for adult patients with esophageal disorders.