An interventional study of Laborie LMT Pharyngeal System (3.7 mm catheter) and Medtronic ManoScan ESO HRM System (4.2 mm catheter) in Dysphagia, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
This study will include a data collection session that involves swallowing tasks during HRM.
Device: Laborie LMT Pharyngeal System (3.7 mm catheter) · Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)
This study will include a data collection session that involves swallowing tasks during HRM.
Device: Laborie LMT Pharyngeal System (3.7 mm catheter) · Device: Medtronic ManoScan ESO HRM System (4.2 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.
Also known as: Laborie HRM impedance system, Laborie Solar™ GI HRM Solid-State, Trolley System (G3-9), Laborie Solid State HRIM Catheter (K83659-E-1820-D)
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.
Also known as: Medtronic HRM impedance system, Medtronic ManoScan™ ESO high resolution manometry system, Medtronic ManoScan360 HRM catheter
Base of tongue pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Hypopharyngeal peak pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Pharyngeal Contractile Integral (PhCI)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Pressure rise time
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Contractile front velocity
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Upper Esophageal Sphincter (UES) resting pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
UES peak contraction pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
UES relaxation nadir pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
UES relaxation duration
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Nadir impedance
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Bolus presence time
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Flow interval
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Pressure-flow index component
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Timing relationships (onset-to-peak intervals)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Time frame: data collected during 1 study visit (up to 2 hours)
Construction of Spatial pressure distribution maps
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.
Time frame: data collected during 1 study visit (up to 2 hours)
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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University of Wisconsin, Madison