Standardizing Swallow Pressure Measurements

August 25, 2026 updated by: University of Wisconsin, Madison

Pharyngeal High Resolution Manometry Standardization of Metrics

This study aims to directly compare and contrast swallowing pressure and impedance measurements obtained from two high-resolution manometry (HRM) systems: the Laborie LMT Pharyngeal System and the Medtronic ManoScan ESO HRM System in healthy adult volunteers. The primary objective is to determine how differences in catheter diameter, sensor configuration, and acquisition platforms influence measurement outcomes. Twenty-five healthy adults will participate in a single, approximately 2-hour visit; the study will be open for one year for data collection and two years for data analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective is to obtain, compare, and contrast directly the measured swallow between the Laborie Pharyngeal HRM impedance system with the 3.7 mm catheter and the Medtronic HRM impedance system with the 4.2 mm catheter in the same setting with normal healthy volunteers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)
  • Inability to follow direction or remain calm during the experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Laborie then Medtronic
This study will include a data collection session that involves swallowing tasks during HRM.
Device: Laborie LMT Pharyngeal System (3.7 mm catheter)
The Solar GI HRM system is intended to record, store, view, and analyze pressure, impedance, EMG, swallow and respiration, and various auxiliary input device data online anywhere in the gastrointestinal tract (pharynx; esophagus; stomach; duodenum; sphincter of Oddi; small bowel; colon and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Used with 3.7 mm catheter.
Other Names:
  • Laborie HRM impedance system
  • Laborie Solar™ GI HRM Solid-State, Trolley System (G3-9)
  • Laborie Solid State HRIM Catheter (K83659-E-1820-D)
Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)
The ManoScan™ ESO high resolution manometry system enables full evaluation of the motor functions of the esophagus. The system provides useful information to support diagnosis of conditions like dysphagia, achalasia, and hiatal hernia. A 36-channel circumferential solid-state catheter with 4.2 mm diameter, 1.0 cm spacing between adjacent sensors.
Other Names:
  • Medtronic HRM impedance system
  • Medtronic ManoScan™ ESO high resolution manometry system
  • Medtronic ManoScan360 HRM catheter
Experimental: Medtronic then Laborie
This study will include a data collection session that involves swallowing tasks during HRM.
Device: Laborie LMT Pharyngeal System (3.7 mm catheter)
The Solar GI HRM system is intended to record, store, view, and analyze pressure, impedance, EMG, swallow and respiration, and various auxiliary input device data online anywhere in the gastrointestinal tract (pharynx; esophagus; stomach; duodenum; sphincter of Oddi; small bowel; colon and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Used with 3.7 mm catheter.
Other Names:
  • Laborie HRM impedance system
  • Laborie Solar™ GI HRM Solid-State, Trolley System (G3-9)
  • Laborie Solid State HRIM Catheter (K83659-E-1820-D)
Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)
The ManoScan™ ESO high resolution manometry system enables full evaluation of the motor functions of the esophagus. The system provides useful information to support diagnosis of conditions like dysphagia, achalasia, and hiatal hernia. A 36-channel circumferential solid-state catheter with 4.2 mm diameter, 1.0 cm spacing between adjacent sensors.
Other Names:
  • Medtronic HRM impedance system
  • Medtronic ManoScan™ ESO high resolution manometry system
  • Medtronic ManoScan360 HRM catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Base of tongue pressure
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Hypopharyngeal peak pressure
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Pharyngeal Contractile Integral (PhCI)
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Pressure rise time
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Contractile front velocity
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Upper Esophageal Sphincter (UES) resting pressure
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
UES peak contraction pressure
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
UES relaxation nadir pressure
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
UES relaxation duration
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Nadir impedance
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Bolus presence time
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Flow interval
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Pressure-flow index component
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Timing relationships (onset-to-peak intervals)
Time Frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
data collected during 1 study visit (up to 2 hours)
Construction of Spatial pressure distribution maps
Time Frame: data collected during 1 study visit (up to 2 hours)
Multi-level modeling for repeated measures across bolus types, volumes, and repetitions. Sensor-level and region-level analyses (BOT, hypopharynx, UES). Agreement thresholds and bias definitions added to facilitate interpretability and ensure clarity for cross-platform comparison. Map layers will be summarized as a proxy for this measure.
data collected during 1 study visit (up to 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy McCulloch, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-1642
  • SMPH | Otolaryngology (Other Identifier: UW Madison)
  • Protocol Version 4/28/26 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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