[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04503785":3,"trial-entities:NCT04503785":90,"trial-summary:NCT04503785":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":35,"secondary_outcomes":40,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":57,"locations":60,"central_contacts":82,"overall_officials":85,"references":88,"see_also_links":89},"NCT04503785","1701721848","Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring","RECRUITING","2027-12-31","2025-09","2026-06-16","2017-01-17","Indiana University","OTHER",false,"Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis","Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia, difficulty swallowing, is one of the most common issues in gastroenterology. In many patients, esophageal obstruction is not identified despite workup with upper endoscopy or barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently being used in clinical practice. However, correlation of the results obtained from these tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the relationship between esophageal impedance-manometry and EndoFLIP results has never been defined.\n\nThe primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital",[18],"Dysphagia, Esophageal",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},1000,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"DIAGNOSTIC_TEST","Manometry","Transnasal Esophageal manometry and Endoflip Balloon distensibility",[32],"Dysphagia",[34],"Endoflip",[36],{"measure":37,"description":38,"timeFrame":39},"Endoflip parameters for gastroparesis","Compare the distensibility index (mm2\u002FmmHg) of the pylorus at 50 ml distension in patients with postsurgical gastroparesis and compare to patients with idiopathic and diabetic gastroparesis.","5 years",[41,44],{"measure":42,"description":43,"timeFrame":39},"Correlation between endoflip parameters and gastric scintigraphy","Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of delayed gastric emptying in patients with gastroparesis",{"measure":45,"description":46,"timeFrame":39},"Correlation between endoflip parameters and symptom severity","Correlate distensibility data (cross-sectional area, pressure, distensibility index) with severity of gastroparesis symptoms by Patient Assessment GI-Ssymptoms (PAGI-SYM)","ALL","18 Years","99 Years",{"inclusion":51,"exclusion":53,"raw_text":56},[52],"All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and\u002For EndoFLIP",[54,55],"Age \\\u003C18 yrs old","Unable to communicate verbally with the staff","Inclusion Criteria:\n\n* All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and\u002For EndoFLIP\n\nExclusion Criteria:\n\n* Age \\\u003C18 yrs old\n* Unable to communicate verbally with the staff",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":79},"Indiana University Health University Hospital","Indianapolis","Indiana","46202","United States",[68,73,76],{"name":69,"role":70,"phone":71,"email":72},"Lainna Cohen","CONTACT","317-278-0621","larcohen@iu.edu",{"name":74,"role":70,"email":75},"Maureen Schilling","maschi@iu.edu",{"name":77,"role":78},"John Wo, MD","PRINCIPAL_INVESTIGATOR",{"lat":80,"lon":81},39.76838,-86.15804,[83,84],{"name":69,"role":70,"email":72},{"name":74,"role":70,"email":75},[86],{"name":87,"affiliation":12,"role":78},"John M Wo, MD",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[32,92],"Esophageal Disorder",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study with a planned enrollment of 1000 participants. It is not a treatment study but rather collects information from existing diagnostic tests.","completed","Observational Study of Esophageal Tests for Dysphagia","This observational study is looking at people who have difficulty swallowing (dysphagia) and a known esophageal diagnosis. Researchers are comparing two common diagnostic tests: esophageal manometry-impedance and the Endolumenal Functional Lumen Imaging Probe (EndoFLIP). Both tests measure different aspects of how your esophagus (the tube that carries food to your stomach) works. The goal is to understand how the results from these tests relate to each other and to your symptoms. You can participate if you are between 18 and 99 years old and have already had or are scheduled for these tests at the GI Motility Lab at IU University Hospital. The study aims to create a registry of information from these tests over five years.","The primary endpoint, Endoflip parameters for gastroparesis, will be measured at 5 years.",117,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]