[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551810":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":364,"collaborators":366,"id":369,"slug":370,"hasResults":371,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":371,"sex":377,"minAge":378,"maxAge":24,"enrollmentInfo":379,"targetDuration":24,"studyType":382,"phases":383,"briefSummary":385,"conditions":386,"keywords":389,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},{"fullName":5,"class":6},"Enterra Medical, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ON Group","EXPERIMENTAL","Participants assigned to the ON treatment group will begin with specified device programming values at the randomization visit. Device programming values may be adjusted at follow-up study visits during the blinding period.\n\nAt the conclusion of the 4-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator. Investigators may adjust programming values at additional follow-up study visits.",[13],"Device: Enterra Therapy System",{"label":15,"type":10,"description":16,"interventionNames":17},"OFF Group","Participants assigned to the OFF treatment group will begin with device programming values set to off at the randomization visit. These settings will continue until the 4-month visit.\n\nAt the conclusion of the 4-month visit, participants will receive specified device programming values. Device programming values may be adjusted at follow-up study visits. At the conclusion of the 8-month visit, participants will have their devices programmed to individualized therapy as determined by the Investigator.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Enterra Therapy System","The Enterra Therapy System is a gastric electrical stimulator system consisting of an implantable pulse generator (Enterra II Model 37800 neurostimulator); two implantable unipolar leads (Enterra Model 4351-35 intramuscular); and device programmer (N'Vision Clinician Programmer Model 8840 with Model 8870 Application Card).\n\nThe programmable neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation through the implanted lead system. A clinician programmer is used to program the neurostimulator and adjust stimulation settings to programmable parameters and stimulation options.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Jason Hamann, PhD","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Timothy McAllister","CONTACT","855-768-3772","clinicalresearch@enterramedical.com",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":37},"Hannah Bearinger, PhD","hannah.bearinger@brightresearch.com",[39,63,76,88,108,129,142,162,185,198,211,228,241,254,267,279,290,306,320,334,343,355],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Mayo Clinic Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-111.89903,33.50921,{"lat":51,"lon":50},[54,57,60],{"name":55,"role":32,"phone":24,"phoneExt":24,"email":56},"Aubrey Smith","Smith.Aubrey@mayo.edu",{"name":58,"role":32,"phone":24,"phoneExt":24,"email":59},"Alexandria Ramirez","Ramirez.Alexandria@mayo.edu",{"name":61,"role":62,"phone":24,"phoneExt":24,"email":24},"William Hasler, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":41,"city":65,"state":66,"zip":67,"country":45,"countryCode":46,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Keck Medicine of USC","Los Angeles","California","90033",{"type":48,"coordinates":69},[70,71],-118.24368,34.05223,{"lat":71,"lon":70},[74],{"name":75,"role":62,"phone":24,"phoneExt":24,"email":24},"Caitlin Houghton, MD",{"facility":77,"status":41,"city":78,"state":66,"zip":79,"country":45,"countryCode":46,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Hoag Hospital","Newport Beach","92663",{"type":48,"coordinates":81},[82,83],-117.92895,33.61891,{"lat":83,"lon":82},[86],{"name":87,"role":62,"phone":24,"phoneExt":24,"email":24},"Christy Dunst, MD",{"facility":89,"status":41,"city":90,"state":66,"zip":91,"country":45,"countryCode":46,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Sutter Health","San Francisco","94109",{"type":48,"coordinates":93},[94,95],-122.41942,37.77493,{"lat":95,"lon":94},[98,102,106],{"name":99,"role":32,"phone":100,"phoneExt":24,"email":101},"Stefanie Roberts","415-600-1107","Stefanie.roberts@sutterhealth.org",{"name":103,"role":32,"phone":104,"phoneExt":24,"email":105},"Christie Linh","415-600-5764","Christie.linh@sutterhealth.org",{"name":107,"role":62,"phone":24,"phoneExt":24,"email":24},"Mimi Lin, MD",{"facility":109,"status":41,"city":110,"state":111,"zip":112,"country":45,"countryCode":46,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"University of South Florida","Tampa","Florida","33606",{"type":48,"coordinates":114},[115,116],-82.45843,27.94752,{"lat":116,"lon":115},[119,123,127],{"name":120,"role":32,"phone":121,"phoneExt":24,"email":122},"Ilexsius Fiorillo","813-844-7650","ilexsius@usf.edu",{"name":124,"role":32,"phone":125,"phoneExt":24,"email":126},"Beth Montera","813-844-7948","bmontera@usf.edu",{"name":128,"role":62,"phone":24,"phoneExt":24,"email":24},"Joseph Sujka, MD",{"facility":130,"status":41,"city":131,"state":132,"zip":133,"country":45,"countryCode":46,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Endeavor Health","Evanston","Illinois","60201",{"type":48,"coordinates":135},[136,137],-87.69006,42.04114,{"lat":137,"lon":136},[140],{"name":141,"role":62,"phone":24,"phoneExt":24,"email":24},"Herbert M Hedberg, MD",{"facility":143,"status":41,"city":144,"state":145,"zip":146,"country":45,"countryCode":46,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Indiana University Health","Indianapolis","Indiana","46202",{"type":48,"coordinates":148},[149,150],-86.15804,39.76838,{"lat":150,"lon":149},[153,157,159],{"name":154,"role":32,"phone":155,"phoneExt":24,"email":156},"Maureen Schilling","317-278-2064","maschi@iu.edu",{"name":158,"role":62,"phone":24,"phoneExt":24,"email":24},"Thomas Nowak, MD",{"name":160,"role":161,"phone":24,"phoneExt":24,"email":24},"John Wo, MD","SUB_INVESTIGATOR",{"facility":163,"status":41,"city":164,"state":165,"zip":166,"country":45,"countryCode":46,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"University of Louisville","Louisville","Kentucky","40202",{"type":48,"coordinates":168},[169,170],-85.75941,38.25424,{"lat":170,"lon":169},[173,177,180,181,183],{"name":174,"role":32,"phone":175,"phoneExt":24,"email":176},"Amy Perdue, RN","502-560-8413","amy.perdue@louisville.edu",{"name":178,"role":32,"phone":24,"phoneExt":24,"email":179},"Abigail Stocker, MD","abigail.stocker@louisville.edu",{"name":178,"role":62,"phone":24,"phoneExt":24,"email":24},{"name":182,"role":161,"phone":24,"phoneExt":24,"email":24},"Carmelita Moppins, APRN",{"name":184,"role":161,"phone":24,"phoneExt":24,"email":24},"Lindsay McElmurray, PA-C",{"facility":186,"status":41,"city":187,"state":188,"zip":189,"country":45,"countryCode":46,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Hackensack Meridian","Neptune City","New Jersey","07753",{"type":48,"coordinates":191},[192,193],-74.02792,40.20011,{"lat":193,"lon":192},[196],{"name":197,"role":62,"phone":24,"phoneExt":24,"email":24},"Seth Kipnis, MD",{"facility":199,"status":41,"city":200,"state":201,"zip":202,"country":45,"countryCode":46,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":48,"coordinates":204},[205,206],-81.69541,41.4995,{"lat":206,"lon":205},[209],{"name":210,"role":62,"phone":24,"phoneExt":24,"email":24},"Anthony Lembo, MD",{"facility":212,"status":41,"city":213,"state":214,"zip":215,"country":45,"countryCode":46,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Temple Digestive Disease Center","Philadelphia","Pennsylvania","19140",{"type":48,"coordinates":217},[218,219],-75.16362,39.95238,{"lat":219,"lon":218},[222,226],{"name":223,"role":32,"phone":224,"phoneExt":24,"email":225},"Alexis Bailey","215-707-7340","alexis.bailey1@temple.edu",{"name":227,"role":62,"phone":24,"phoneExt":24,"email":24},"Henry P Parkman, MD",{"facility":229,"status":41,"city":230,"state":231,"zip":232,"country":45,"countryCode":46,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Baylor College of Medicine","Houston","Texas","77030",{"type":48,"coordinates":234},[235,236],-95.36327,29.76328,{"lat":236,"lon":235},[239],{"name":240,"role":62,"phone":24,"phoneExt":24,"email":24},"Reena Chokshi, MD",{"facility":242,"status":41,"city":243,"state":24,"zip":24,"country":244,"countryCode":245,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"UZ Leuven","Leuven","Belgium","BE",{"type":48,"coordinates":247},[248,249],4.70093,50.87959,{"lat":249,"lon":248},[252],{"name":253,"role":62,"phone":24,"phoneExt":24,"email":24},"Jan Tack, MD\u002FPhD",{"facility":255,"status":41,"city":256,"state":24,"zip":24,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Hôpital Louis-Mourier","Colombes","France","FR",{"type":48,"coordinates":260},[261,262],2.25404,48.91882,{"lat":262,"lon":261},[265],{"name":266,"role":62,"phone":24,"phoneExt":24,"email":24},"Heithem Soliman, MD",{"facility":268,"status":41,"city":269,"state":24,"zip":270,"country":257,"countryCode":258,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Hôpital Edouard Herriot - CHU de Lyon","Lyon","69003",{"type":48,"coordinates":272},[273,274],4.84789,45.74906,{"lat":274,"lon":273},[277],{"name":278,"role":62,"phone":24,"phoneExt":24,"email":24},"François Mion, MD",{"facility":280,"status":41,"city":281,"state":24,"zip":24,"country":257,"countryCode":258,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"CHU de Bordeaux","Pessac",{"type":48,"coordinates":283},[284,285],-0.6324,44.80565,{"lat":285,"lon":284},[288],{"name":289,"role":62,"phone":24,"phoneExt":24,"email":24},"Frank Zerbib, MD",{"facility":291,"status":41,"city":292,"state":24,"zip":293,"country":257,"countryCode":258,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"CHU de Rouen","Rouen","76031",{"type":48,"coordinates":295},[296,297],1.09932,49.44313,{"lat":297,"lon":296},[300,302,304],{"name":301,"role":62,"phone":24,"phoneExt":24,"email":24},"Guillaume Gourcerol",{"name":303,"role":161,"phone":24,"phoneExt":24,"email":24},"Charlotte Desprez",{"name":305,"role":161,"phone":24,"phoneExt":24,"email":24},"Chloé Melchior",{"facility":307,"status":41,"city":308,"state":24,"zip":309,"country":310,"countryCode":311,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Sahlgrenska Universitetssjukhuset","Gothenburg","413 45","Sweden","SE",{"type":48,"coordinates":313},[314,315],11.96679,57.70716,{"lat":315,"lon":314},[318],{"name":319,"role":62,"phone":24,"phoneExt":24,"email":24},"Hans Törnblom, MD, PhD",{"facility":321,"status":41,"city":322,"state":24,"zip":323,"country":324,"countryCode":325,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"University College London Hospital","London","NW1 6DB","United Kingdom","UK",{"type":48,"coordinates":327},[328,329],-0.12574,51.50853,{"lat":329,"lon":328},[332],{"name":333,"role":62,"phone":24,"phoneExt":24,"email":24},"Natalia Zarate-Lopez, PhD",{"facility":335,"status":41,"city":322,"state":24,"zip":336,"country":324,"countryCode":325,"cosmosGeoPoint":337,"geoPoint":339,"contacts":340},"King's College Hospital NHS Foundation Trust","SE5 9RS",{"type":48,"coordinates":338},[328,329],{"lat":329,"lon":328},[341],{"name":342,"role":62,"phone":24,"phoneExt":24,"email":24},"Bu'Hussain Hayee, PhD",{"facility":344,"status":41,"city":345,"state":24,"zip":346,"country":324,"countryCode":325,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Manchester University NHS Foundation Trust","Manchester","M23 9LT",{"type":48,"coordinates":348},[349,350],-2.23743,53.48095,{"lat":350,"lon":349},[353],{"name":354,"role":62,"phone":24,"phoneExt":24,"email":24},"Dipesh Vasant, PhD",{"facility":356,"status":41,"city":345,"state":24,"zip":357,"country":324,"countryCode":325,"cosmosGeoPoint":358,"geoPoint":360,"contacts":361},"Functional Gut Clinic","M3 4BG",{"type":48,"coordinates":359},[349,350],{"lat":350,"lon":349},[362],{"name":363,"role":62,"phone":24,"phoneExt":24,"email":24},"Paul Goldsmith, MD",{"type":365,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[367],{"name":368,"class":6},"Bright Research Partners","100551810","chronic-nausea-and-vomiting-in-patients-with-normal-gastric-emptying-using-the-enterra-therapy-system-navigate-100551810",false,"NCT06464926","Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)","A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System","NAVIGATE","Inclusion Criteria:\n\n* Willing and able to complete the informed consent process\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged ≥18 years at time of informed consent\n* Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent\n* Patient is able to complete ANMS GCSI-DD surveys on a compatible smart device with: a) a minimum of four (4) ANMS GCSI-DD entries per week for two consecutive weeks, and b) an average ANMS GCSI-DD score for nausea severity of ≥2.5 during the same two-week period\n* Refractory or intolerant to two or more of the following antiemetic drug classes: antihistamines, phenothiazines, serotonin type 3 receptor antagonists, dopamine type 2 receptor antagonists, anticholinergics, neurokinin receptor antagonists\n* Medically stable, in the opinion of the investigator, during the month prior to consent, with no planned modifications to medical therapy during the course of the study\n* Normal gastric emptying as assessed by a qualifying gastric emptying test performed within 2 years of consent if no prior pyloric transection therapy, or within 2 years of consent and after the most recent pyloric transection therapy\n* Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum) performed within 1 year of consent if no prior pyloric transection therapy, or within 1 year of consent and after the most recent pyloric transection therapy\n\nExclusion Criteria:\n\n* Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements\n* Pyloric transection therapy completed within 1 year of consent\n* Documented gastrointestinal (GI) obstruction or pseudo-obstruction\n* History of primary swallowing disorders\n* History of primary psychogenic vomiting\n* History of primary eating disorder\n* History of cyclic vomiting syndrome\n* History of rumination syndrome\n* History of scleroderma\n* History of amyloidosis\n* History of cannabis hyperemesis syndrome\n* Active H. pylori infection\n* Evidence of bezoar during most recent endoscopy\n* Previous gastric surgery of any type other than a pyloric transection therapy (i.e., pyloroplasty, pyloromyotomy, POP, or G-POEM)\n* Uncontrolled thyroid disorder, in the opinion of the investigator\n* History of seizures disorders\n* Hemoglobin A1c \\>8.0%\n* Peritoneal dialysis or unstable hemodialysis\n* Parenteral or enteral nutritional support\n* Active pancreatitis\n* History of organ transplant, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease\n* Other GI tract diseases and disorders that the investigator believes may have caused the patient's drug-refractory nausea and\u002For vomiting\n* Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of consent\n* Opioid use\n* Current cannabis\u002Fcannabinoid use that exceeds: 3 days of usage per week, or 2 occurrences during each day of use, or 3 grams of total usage per week\n* Heavy alcohol use, defined as: for men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more drinks on any day or 8 or more per week\n* Injection of Botox into the pyloric sphincter within 6 months of consent\n* Active major levels of anxiety\u002Fdepression, as determined by the investigator\n* History of other clinically significant disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact the validity of the study results\n* Life expectancy \\\u003C1 year\n* Pregnant or breastfeeding at the time of consent or intend to become pregnant during the study\n* Any underlying disease leading to follow-up by MRI outside of current MR conditional indications\n* Glucagon-like peptide 1 (GLP-1) agonist drug use within 6 months of consent\n* Participation in other investigational clinical studies\n* Existing or prior gastric electrical stimulator implantation","ALL","18 Years",{"count":380,"type":381},148,"ESTIMATED","INTERVENTIONAL",[384],"NA","The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.",[387,388],"Nausea","Vomiting",[390,387,388,391],"Chronic","Gastric Electrical Stimulation","2026-05-11",{"date":394,"type":395},"2026-05-14","ACTUAL",{"date":397,"type":395},"2025-06-23",{"date":399,"type":381},"2030-06",{"name":5,"class":6},22]