Health TrialsbyHealthPanel

Standardizing Swallow Pressure Measurements

ConditionDysphagia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

without known swallowing disorders

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Laborie then MedtronicExperimental treatment 2 interventions
Group B: Medtronic then LaborieExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov

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