Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SMPH | Otolaryngology | Other Identifier | UW Madison | |
| Protocol Version 4/28/26 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laborie then Medtronic | Experimental | This study will include a data collection session that involves swallowing tasks during HRM. |
|
| Medtronic then Laborie | Experimental | This study will include a data collection session that involves swallowing tasks during HRM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laborie LMT Pharyngeal System (3.7 mm catheter) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Base of tongue pressure | Measured with both Laborie HRM impedance system and Medtronic HRM impedance system for comparison. | 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. | 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. | 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. | 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. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suzan Abdelhalim, MD | Contact | 608-265-2470 | abdelhalim@surgery.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Timothy McCulloch, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004194 | Disease |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
|
|
| Medtronic ManoScan ESO HRM System (4.2 mm catheter) | Device | 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. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | data collected during 1 study visit (up to 2 hours) |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |