Standardizing Swallow Pressure Measurements

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07475091
Status
Not Yet Recruiting

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Conditions

  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Laborie then Medtronic
    This study will include a data collection session that involves swallowing tasks during HRM.
  • Experimental: Medtronic then Laborie
    This study will include a data collection session that involves swallowing tasks during HRM.

Primary Outcome Measure

Base of tongue pressure [ Time Frame: data collected during 1 study visit (up to 2 hours) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53792-

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By research site
University of Wisconsin· Madison, WI

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