[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Enterra Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},148,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Nausea","Vomiting",[30,27,28,31],"Chronic","Gastric Electrical Stimulation","RECRUITING","2026-05-11",{"date":35,"type":36},"2026-05-14","ACTUAL",{"date":38,"type":36},"2025-06-23",{"date":40,"type":21},"2030-06",{"name":42,"class":43},"Enterra Medical, Inc.","INDUSTRY",22,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100559144","study-of-enhanced-programming-stimulation-with-the-enterra-therapy-system-100559144","NCT06560307","Study of Enhanced Programming Stimulation with the Enterra® Therapy System","Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation","EXPEDITE","Inclusion Criteria:\n\n1. Completed informed consent process with signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation\n4. Diagnosed with idiopathic or diabetic gastroparesis\n5. Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as \\> 60% retained at 2 hours and\u002For \\>10% retained at 4 hours\n6. Investigator confirms normal endoscopy within one year of enrollment in the study\n7. GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week\n\nExclusion Criteria:\n\n1. Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator\n2. History of pyloroplasty or pyloromyotomy or G-POEM\n3. Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study\n4. Active H. pylori infection\n5. Significant hepatic injury (elevated ALT, AST, bilirubin)\n6. Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction\n7. Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions\n8. Participation in other clinical studies\n9. Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)\n10. Cannabis and\u002For cannabinoid use that exceeds either:\n\n    1. Greater than 3 days of usage per week with 2 or less occurrences each day of use, or\n    2. Greater than 3 grams of total usage per week\n11. Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension\n12. Subject experiences discomfort during stimulation assessment that cannot be tolerated\n13. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications\n14. Evidence of a failed response to temporary gastric electrical stimulation","70 Years",{"count":55,"type":21},50,[24],"The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures.\n\nParticipants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone\u002Ftablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits.\n\nParticipants will be involved in the study for up to six months after treatment assignment.\n\nProgramming parameters in the study are within currently approved labeling.",[59,60,61],"Gastroparesis","Gastroparesis Nondiabetic","Gastroparesis Due to Diabetes Mellitus",[63,59],"Gastric electrical stimulation","2024-11-13",{"date":66,"type":36},"2024-11-15",{"date":68,"type":36},"2024-07-25",{"date":70,"type":21},"2026-12",{"name":42,"class":43},6,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100514588","study-of-enterra-programming-with-nocturnal-cycling-in-gastroparetics-100514588","NCT05980455","Study of Enterra Programming with Nocturnal Cycling in Gastroparetics","Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics","RESTING","In order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n1. Completed informed consent process with signed and dated informed consent form;\n2. Stated willingness to comply with all study procedures and availability for the duration of the study;\n3. Male or female, aged ≥18 or ≤70 at time of informed consent;\n4. Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);\n5. High GES output defined as remaining pulse generator expected life of \\> 9 months from enrollment and less than 4 years from the time of implant;\n6. Stable gastroparesis symptoms, in the opinion of the investigator;\n7. On stable medical therapy for gastroparesis symptoms;\n8. On stable supplemental nutritional support during the month prior to enrollment;\n9. English language comprehension to complete study-required assessments;\n10. Reliable access to internet-connected smart device(s) to complete study-required assessments.\n\nA participant who meets any of the following criteria will be excluded from participation in this study:\n\n1. Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator;\n2. Subjects, in the opinion of the investigator, with profound nausea and\u002For vomiting at night;\n3. Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;\n4. Subjects without a regular and defined sleep schedule;\n5. Pregnancy, or subject that intends to become pregnant during participation in the study;\n6. Chemical dependency;\n7. Enterra lead impedance measurements ≥ 700 Ohms at screening visit;\n8. Life expectancy \\\u003C 1 year from conditions other than GI diseases;\n9. Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;\n10. Participation in other clinical studies;\n11. Subjects involved in current or past medical-related litigation;\n12. Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.",{"count":55,"type":21},[24],"The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures.\n\nParticipants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone\u002Ftablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at study visits.\n\nParticipants will be involved in the study for up to six months after treatment assignment.\n\nProgramming parameters in the study are within currently approved labeling.",[59,60,61],[63,59],{"date":66,"type":36},{"date":88,"type":36},"2023-07-10",{"date":90,"type":21},"2025-12",{"name":42,"class":43},2,""]