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NCT Number: NCT07475091

Standardizing Swallow Pressure Measurements

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Disease Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laborie LMT Pharyngeal System (3.7 mm catheter)

Device

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)

Medtronic ManoScan ESO HRM System (4.2 mm catheter)

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Suzan Abdelhalim, MD

CONTACT

[email protected]

608-265-2470

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Pharyngeal High Resolution Manometry Standardization of Metrics

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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