Standardizing Swallow Pressure Measurements

University of Wisconsin (UW)

Status: Begins enrollment this month

Conditions: Dysphagia

Treatments: Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter); Device: Laborie LMT Pharyngeal System (3.7 mm catheter)

Study type: Interventional

Funder types: Other

Identifiers

NCT07475091

2025-1642

Protocol Version 12/30/25 (Other Identifier)

SMPH | Otolaryngology (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Laborie then Medtronic

Experimental group

Description:

This study will include a data collection session that involves swallowing tasks during HRM.

Treatment:

Device: Laborie LMT Pharyngeal System (3.7 mm catheter)

Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)

Medtronic then Laborie

Experimental group

Description:

This study will include a data collection session that involves swallowing tasks during HRM.

Treatment:

Device: Laborie LMT Pharyngeal System (3.7 mm catheter)

Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)