NCT07475091

Standardizing Swallow Pressure Measurements

Pharyngeal High Resolution Manometry Standardization of Metrics

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study