Manometry Systems for Swallowing Difficulty

SA
Overseen BySuzan Abdelhalim, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different high-resolution manometry (HRM) systems to measure swallowing pressure and impedance (resistance). The goal is to compare these systems based on catheter size and sensor setup. Researchers seek healthy adults without known swallowing issues to participate. Each participant will complete a single session, performing swallowing tasks using the HRM systems. As an unphased trial, this study allows participants to contribute to advancing medical technology in a non-invasive setting.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to check with the study team for guidance.

What prior data suggests that these manometry systems are safe for use in healthy adults?

Research has shown that high-resolution manometry (HRM), used in the study, is generally safe for assessing swallowing problems. One study found that HRM has few side effects. Some participants experienced mild sore throats, sinus irritation, nosebleeds, or a temporary fast heartbeat. These effects were mild and rare. Overall, HRM is well-tolerated, making it a reliable method for evaluating swallowing difficulties.12345

Why are researchers excited about this trial?

Researchers are excited about the use of high-resolution manometry (HRM) for swallowing difficulties because it provides detailed pressure measurements along the esophagus. Unlike traditional methods that might only capture generalized data, HRM offers precise and comprehensive insights into how the muscles in the esophagus work during swallowing. This level of detail can help doctors pinpoint specific dysfunctions and tailor treatments more effectively. By comparing different systems like Laborie and Medtronic, researchers hope to identify the most effective way to gather and utilize this high-resolution data, ultimately improving diagnosis and treatment plans for patients with swallowing difficulties.

What evidence suggests that these manometry systems are effective for swallowing difficulty?

Studies have shown that high-resolution manometry (HRM) effectively diagnoses swallowing problems. One study found esophageal issues in 58.6% of patients who had normal results on other tests but still experienced swallowing difficulties. HRM provides a detailed view of esophageal function, which is especially helpful for those with unexplained swallowing issues. It is more accurate and easier to use than older methods, making it a valuable option for diagnosing swallowing disorders. In some cases, HRM can detect problems that other tests might miss, such as certain muscle spasms or very strong muscle contractions (jackhammer esophagus). This trial will compare two HRM systems, Laborie and Medtronic, to further understand their effectiveness in identifying and understanding swallowing problems.16789

Who Is on the Research Team?

TM

Timothy McCulloch, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for healthy adults without any known swallowing problems, who do not have allergies to topical anesthetics or foods used in the study, and can follow instructions and stay calm during testing.

Inclusion Criteria

Without known swallowing disorders

Exclusion Criteria

Known swallowing disorder
Allergy to topical anesthetic
Allergy to food relevant to study participation (e.g. lactose intolerance)
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

Participants undergo a single data collection session involving swallowing tasks using HRM systems

1 day
1 visit (in-person, up to 2 hours)

Follow-up

Participants are monitored for any immediate adverse effects post data collection

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • High-Resolution Manometry

Trial Overview

The study compares two devices that measure swallowing pressure: the Medtronic ManoScan ESO HRM System and the Laborie LMT Pharyngeal System. Each participant will try both systems in a single visit to see how device differences affect results.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Medtronic then LaborieExperimental Treatment2 Interventions
Group II: Laborie then MedtronicExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Citations

Utility of High‐Resolution Esophageal Manometry in ... - PMC

HREM identified esophageal pathologies in 58.6% of patients with OD symptoms and normal MBSS, highlighting its value in the diagnostic workup of ...

Diagnostic Yield of High-resolution Esophageal Manometry ...

Esophageal manometry provided the highest yield in dysphagia; it was not a strongly beneficial test in patients presenting with non-dysphagia.

AI in Esophageal Motility Disorders: Systematic Review ...

Background: High-resolution esophageal manometry (HRM) is essential for diagnosing esophageal motility disorders, affecting 10%-15% of ...

High-Resolution Manometry in Clinical Practice

HRM/EPT provides a detailed assessment of esophageal function that is useful in the evaluation of patients with nonobstructive dysphagia and before foregut ...

Clinical utility of the solid meal test during high-resolution ...

The STM diagnosed 21% more major motor disorders than the conventional protocol; it doubled the cases of esophageal spasm and quadrupled the cases of jackhammer ...

Safety and Tolerability of High-Resolution Esophageal...

HRM is considered a safe procedure with minimal adverse events including mild sore throat, sinus irritation, nosebleed, tachycardia, and increase in blood ...

High Resolution Manometry for Swallowing (HRM)

A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

Pharyngeal High‐Resolution Manometry‐Based Evaluation of ...

Both patients regained sufficient swallowing function to resume a regular diet. P‐HRM‐I may be a useful tool for quantitatively assessing UES ...

Safety and Tolerability of Pharyngeal High-Resolution ...

Pharyngeal high-resolution manometry is an emerging practice for diagnosis of swallowing disorders in the upper aerodigestive tract.