DysphagiaNCT07475091
Standardizing Swallow Pressure Measurements
A study testing Laborie LMT Pharyngeal System (3.7 mm catheter) and Medtronic ManoScan ESO HRM System (4.2 mm catheter) in people with Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Laborie LMT Pharyngeal System (3.7 mm catheter) and Medtronic ManoScan ESO HRM System (4.2 mm catheter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- without known swallowing disorders
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pharyngeal High Resolution Manometry Standardization of Metrics
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.
Read the 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
- Being tested
- Laborie LMT Pharyngeal System (3.7 mm catheter), Medtronic ManoScan ESO HRM System (4.2 mm catheter)
- Keywords
- pharyngeal pressure events, swallowing, measurement, diagnosis
- Medical subject headings
- Deglutition Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laborie LMT Pharyngeal System (3.7 mm catheter)Device
Also called Laborie HRM impedance system, Laborie Solar™ GI HRM Solid-State, Trolley System (G3-9), Laborie Solid State HRIM Catheter (K83659-E-1820-D)
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
Also called Medtronic HRM impedance system, Medtronic ManoScan™ ESO high resolution manometry system, Medtronic ManoScan360 HRM 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.
| Study group | Role | What they receive |
|---|---|---|
| Laborie then Medtronic | Experimental | This study will include a data collection session that involves swallowing tasks during HRM. Receives: Device: Laborie LMT Pharyngeal System (3.7 mm catheter); Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter) |
| Medtronic then Laborie | Experimental | This study will include a data collection session that involves swallowing tasks during HRM. Receives: Device: Laborie LMT Pharyngeal System (3.7 mm catheter); Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base of tongue pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Hypopharyngeal peak pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Pharyngeal Contractile Integral (PhCI)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Pressure rise time
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Contractile front velocity
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Upper Esophageal Sphincter (UES) resting pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
UES peak contraction pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
UES relaxation nadir pressure
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
UES relaxation duration
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Nadir impedance
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Bolus presence time
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Flow interval
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Pressure-flow index component
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Timing relationships (onset-to-peak intervals)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Measured: data collected during 1 study visit (up to 2 hours)
Construction of Spatial pressure distribution maps
Multi-level modeling for repeated measures across bolus types, volumes, and repetitions. Sensor-level and region-level analyses (BOT, hypopharynx, UES). Agreement thresholds and bias definitions added to facilitate interpretability and ensure clarity for cross-platform comparison. Map layers will be summarized as a proxy for this measure.
Measured: data collected during 1 study visit (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will complete two HRM procedures in a randomized cross-over design with a 1:1 allocation to determine the order of catheter use
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy McCulloch, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475091
- Sponsor's protocol ID
- 2025-1642
- Other IDs
- SMPH | Otolaryngology, Protocol Version 4/28/26
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharyngeal High Resolution Manometry Standardization of Metrics
- ClinicalTrials.gov ID
- NCT07475091
- Acronym / sponsor ID
- 2025-1642
- Conditions
- Dysphagia
- Keywords
- pharyngeal pressure events, swallowing, measurement, diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will complete two HRM procedures in a randomized cross-over design with a 1:1 allocation to determine the order of catheter use
| Arm | Type | Receives |
|---|---|---|
| Laborie then Medtronic | Experimental | Device: Laborie LMT Pharyngeal System (3.7 mm catheter), Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)This study will include a data collection session that involves swallowing tasks during HRM. |
| Medtronic then Laborie | Experimental | Device: Laborie LMT Pharyngeal System (3.7 mm catheter), Device: Medtronic ManoScan ESO HRM System (4.2 mm catheter)This study will include a data collection session that involves swallowing tasks during HRM. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- without known swallowing disorders
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laborie LMT Pharyngeal System (3.7 mm catheter)Also: Laborie HRM impedance system, Laborie Solar™ GI HRM Solid-State, Trolley System (G3-9), Laborie Solid State HRIM Catheter (K83659-E-1820-D)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 | Laborie then Medtronic, Medtronic then Laborie |
| Medtronic ManoScan ESO HRM System (4.2 mm catheter)Also: Medtronic HRM impedance system, Medtronic ManoScan™ ESO high resolution manometry system, Medtronic ManoScan360 HRM catheterThe 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. | Device | Laborie then Medtronic, Medtronic then Laborie |
Primary outcome
Base of tongue pressure
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Hypopharyngeal peak pressure
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Pharyngeal Contractile Integral (PhCI)
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Pressure rise time
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Contractile front velocity
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Upper Esophageal Sphincter (UES) resting pressure
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
UES peak contraction pressure
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
UES relaxation nadir pressure
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
UES relaxation duration
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Nadir impedance
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Bolus presence time
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Flow interval
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Pressure-flow index component
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Timing relationships (onset-to-peak intervals)
Time frame: data collected during 1 study visit (up to 2 hours)
Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison.
Construction of Spatial pressure distribution maps
Time frame: data collected during 1 study visit (up to 2 hours)
Multi-level modeling for repeated measures across bolus types, volumes, and repetitions. Sensor-level and region-level analyses (BOT, hypopharynx, UES). Agreement thresholds and bias definitions added to facilitate interpretability and ensure clarity for cross-platform comparison. Map layers will be summarized as a proxy for this measure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy McCulloch, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laborie LMT Pharyngeal System (3.7 mm catheter) and Medtronic ManoScan ESO HRM System (4.2 mm catheter) in people with Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzan Abdelhalim, MD (608-265-2470, abdelhalim@surgery.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Base of tongue pressure (time frame: data collected during 1 study visit (up to 2 hours)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.