[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411757":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":21,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":21,"enrollmentInfo":73,"targetDuration":21,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":39,"whyStopped":21,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pharmacologic challenge","EXPERIMENTAL","Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)",[13,14],"Drug: Atropine challenge","Procedure: Esophageal muscle biopsy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Atropine challenge","Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg\u002Fkg of intravenous atropine. Two minutes after administration, FLIP will be repeated.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Esophageal muscle biopsy","Esophageal muscle biopsy. During standard-of-care Heller myotomy or per-oral endoscopic myotomy, 5mm of lower esophageal sphincter and distal esophageal circular muscle will be collected via biopsy forceps.",[9],[28],{"name":29,"affiliation":5,"role":30},"Anand Jain, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","404-778-3184","anand.jain@emory.edu",[37,51],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":21},"Emory University Hospital","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-84.38798,33.749,{"lat":49,"lon":48},{"facility":52,"status":39,"city":40,"state":41,"zip":53,"country":43,"countryCode":44,"cosmosGeoPoint":54,"geoPoint":56,"contacts":21},"Emory Saint Joseph's Hospital","30342",{"type":46,"coordinates":55},[48,49],{"lat":49,"lon":48},{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Anand Jain","Principal Investigator",[61],{"name":62,"class":63},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100411757","phase-4-comprehensive-esophageal-diagnostics-study-100411757",false,"NCT04641702","Comprehensive Esophageal Diagnostics Study","Comprehensive Assessment of Histopathologic and Physiologic Profile in Esophageal Motility Disorders","Inclusion Criteria:\n\n1. Male or female patients, age 18 and above.\n2. Evaluated by Emory Digestive Diseases Clinic, Emory Motility Lab, the Emory Endoscopy Unit, or Emory Surgery Department starting October 1, 2020.\n3. Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high-resolution esophageal manometry (for Aim 1)\n4. Undergoing a diagnostic Functional Lumen Imaging Probe (FLIP) study at Emory University Hospital with anesthesia assistance (for Aim 1)\n5. Undergoing Heller myotomy or per oral endoscopic myotomy for the treatment of their esophageal motility disorder (for Aim 2)\n\nExclusion Criteria:\n\n1. Patients younger than 18 years old\n2. Pregnant women\n3. Prisoners\n4. Non-English speaking - the rationale is that the symptom characterization and outcome data are measured on detailed and fairly lengthy (5-7 pages) questionnaires written in English with some medical terms. These are standardized questionnaires with no short forms available.\n5. Cognitively impaired adults unable to provide informed consent\n6. Cardiac disease in the form of - arrhythmia requiring ICD or pacemaker, baseline bradycardia with HR \\\u003C60 or tachycardia with HR \\> 90, congestive heart failure with ejection fraction \\\u003C35%, history of myocardial infarction, baseline MAP \\\u003C65 or systolic BP \\>140, asthma or chronic obstructive pulmonary disease, urinary retention requiring the use of foley catheterization (including intermittent use), narrow-angle glaucoma, myasthenia gravis, GFR \\\u003C60 \\[exclusions for Aim 1 only\\]","ALL","18 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.",[81],"Achalasia",[83,84,85,86],"lower esophageal sphincter","Functional Lumen Imaging Probe Topography","anti-fibrosis agents","anti-inflammatory agents","2025-11-05",{"date":89,"type":90},"2025-11-10","ACTUAL",{"date":92,"type":90},"2021-03-17",{"date":94,"type":75},"2026-12-31",{"name":5,"class":6},2]