[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07475091":3,"trial-entities:NCT07475091":125,"trial-summary:NCT07475091":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":52,"secondary_outcomes":86,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":100,"locations":103,"central_contacts":113,"overall_officials":119,"references":123,"see_also_links":124},"NCT07475091","2025-1642","Standardizing Swallow Pressure Measurements","Pharyngeal High Resolution Manometry Standardization of Metrics","NOT_YET_RECRUITING","2027-09","2026-08","2026-08-28","2026-09","University of Wisconsin, Madison","OTHER",null,"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.",[19],"Dysphagia",[21,22,23,24],"pharyngeal pressure events","swallowing","measurement","diagnosis","INTERVENTIONAL","DIAGNOSTIC",[28],"NA",{"count":30,"type":31},25,"ESTIMATED",[33,44],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"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.",[38,39],"Laborie then Medtronic","Medtronic then Laborie",[41,42,43],"Laborie HRM impedance system","Laborie Solar™ GI HRM Solid-State, Trolley System (G3-9)","Laborie Solid State HRIM Catheter (K83659-E-1820-D)",{"type":34,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"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.",[38,39],[49,50,51],"Medtronic HRM impedance system","Medtronic ManoScan™ ESO high resolution manometry system","Medtronic ManoScan360 HRM catheter",[53,57,59,61,63,65,67,69,71,73,75,77,79,81,83],{"measure":54,"description":55,"timeFrame":56},"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)",{"measure":58,"description":55,"timeFrame":56},"Hypopharyngeal peak pressure",{"measure":60,"description":55,"timeFrame":56},"Pharyngeal Contractile Integral (PhCI)",{"measure":62,"description":55,"timeFrame":56},"Pressure rise time",{"measure":64,"description":55,"timeFrame":56},"Contractile front velocity",{"measure":66,"description":55,"timeFrame":56},"Upper Esophageal Sphincter (UES) resting pressure",{"measure":68,"description":55,"timeFrame":56},"UES peak contraction pressure",{"measure":70,"description":55,"timeFrame":56},"UES relaxation nadir pressure",{"measure":72,"description":55,"timeFrame":56},"UES relaxation duration",{"measure":74,"description":55,"timeFrame":56},"Nadir impedance",{"measure":76,"description":55,"timeFrame":56},"Bolus presence time",{"measure":78,"description":55,"timeFrame":56},"Flow interval",{"measure":80,"description":55,"timeFrame":56},"Pressure-flow index component",{"measure":82,"description":55,"timeFrame":56},"Timing relationships (onset-to-peak intervals)",{"measure":84,"description":85,"timeFrame":56},"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.",[],"ALL","18 Years","99 Years",true,{"inclusion":92,"exclusion":94,"raw_text":99},[93],"without known swallowing disorders",[95,96,97,98],"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.","Inclusion Criteria:\n\n* without known swallowing disorders\n\nExclusion Criteria:\n\n* Known swallowing disorder\n* Allergy to topical anesthetic\n* Allergy to food relevant to study participation (e.g. lactose intolerance)\n* Inability to follow direction or remain calm during the experiment.",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":105,"city":106,"state":107,"zip":108,"country":109,"geoPoint":110},"University of Wisconsin","Madison","Wisconsin","53792","United States",{"lat":111,"lon":112},43.07305,-89.40123,[114],{"name":115,"role":116,"phone":117,"email":118},"Suzan Abdelhalim, MD","CONTACT","608-265-2470","abdelhalim@surgery.wisc.edu",[120],{"name":121,"affiliation":13,"role":122},"Timothy McCulloch, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Healthy",[],{"nct_id":4,"found":90,"summary":130,"prompt_version":139},{"design":131,"status":132,"heading":6,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is an interventional study involving 25 healthy adult volunteers. It directly compares two different medical devices in the same setting.","completed","This study is comparing two different medical devices, the Laborie LMT Pharyngeal System and the Medtronic ManoScan ESO HRM System, which are used to measure swallowing pressure. Researchers want to see how differences in these devices, like the size of their catheters (thin tubes), affect the measurements. The goal is to understand if these devices give similar results when measuring how well people swallow. You could be eligible if you are between 18 and 99 years old and do not have any known swallowing problems. The study is looking for 25 healthy adults and is currently unclear about its recruitment status.","Data will be collected during your single study visit. The study will be open for data collection for one year and data analysis for two years.",101,"You would participate in a single study visit lasting up to 2 hours. During this visit, swallowing pressure measurements will be taken.","Not stated in the trial record.",[],"v2"]