Standardizing Swallow Pressure Measurements

NCT07475091 | Not Yet Recruiting FDA Device

• 3 other identifiers: 2025-1642SMPH | OtolaryngologyProtocol Version 4/28/26
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia

Keywords

pharyngeal pressure events; swallowing; measurement; diagnosis

Outcome Measures

Primary Outcomes (15)

• 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)

Study Arms (2)

Laborie then Medtronic

EXPERIMENTAL

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)

Medtronic then Laborie

EXPERIMENTAL

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)

Interventions

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.

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)

Laborie then Medtronic; Medtronic then Laborie

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.

Also known as: Medtronic HRM impedance system, Medtronic ManoScan™ ESO high resolution manometry system, Medtronic ManoScan360 HRM catheter

Laborie then Medtronic; Medtronic then Laborie

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• without known swallowing disorders

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Disease

Interventions

Catheters

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Timothy McCulloch, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzan Abdelhalim, MD

CONTACT

608-265-2470; abdelhalim@surgery.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will complete two HRM procedures in a randomized cross-over design with a 1:1 allocation to determine the order of catheter use

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)