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Standardizing Swallow Pressure Measurements

NCT07475091 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-15

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Timothy McCulloch, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475091 on ClinicalTrials.gov