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Not yet recruiting NCT07475091

Standardizing Swallow Pressure Measurements

No phase Interventional Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laborie LMT Pharyngeal System (3.7 mm catheter), Medtronic ManoScan ESO HRM System (4.2 mm catheter).
Who it may be relevant to
Registry conditions: Dysphagia. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pharyngeal High Resolution Manometry Standardization of Metrics

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Base of tongue pressure [Time frame: 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)]
  • Pharyngeal Contractile Integral (PhCI) [Time frame: 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)]
  • Contractile front velocity [Time frame: 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)]
  • UES peak contraction pressure [Time frame: 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)]
  • UES relaxation duration [Time frame: data collected during 1 study visit (up to 2 hours)]
  • Nadir impedance [Time frame: data collected during 1 study visit (up to 2 hours)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Identifiers

NCT: NCT07475091 · 2025-1642 · SMPH | Otolaryngology · Protocol Version 4/28/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗