Standardizing Swallow Pressure Measurements

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: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Device: Laborie LMT Pharyngeal System (3.7 mm catheter); Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)

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: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzan Abdelhalim, MD; Phone Number: 608-265-2470; Email: abdelhalim@surgery.wisc.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Base of tongue pressure	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	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)	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	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	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	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	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	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	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	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	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	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	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)	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	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

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Timothy McCulloch, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: diagnosis; swallowing; measurement; pharyngeal pressure events
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Disease; Deglutition Disorders; Equipment and Supplies; Catheters
• Other Study ID 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