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NOT YET RECRUITING
NCT07475091
NA

Standardizing Swallow Pressure Measurements

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

Official title: Pharyngeal High Resolution Manometry Standardization of Metrics

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-05

Completion Date

2027-05

Last Updated

2026-03-16

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States