[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroparesis-due-to-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroparesis-due-to-diabetes-mellitus":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100559144","study-of-enhanced-programming-stimulation-with-the-enterra-therapy-system-100559144",false,"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","ALL","18 Years","70 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30],"Gastroparesis","Gastroparesis Nondiabetic","Gastroparesis Due to Diabetes Mellitus",[32,28],"Gastric electrical stimulation","RECRUITING","2024-11-13",{"date":36,"type":37},"2024-11-15","ACTUAL",{"date":39,"type":37},"2024-07-25",{"date":41,"type":22},"2026-12",{"name":43,"class":44},"Enterra Medical, Inc.","INDUSTRY",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":5},"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":21,"type":22},[25],"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.",[28,29,30],[32,28],{"date":36,"type":37},{"date":61,"type":37},"2023-07-10",{"date":63,"type":22},"2025-12",{"name":43,"class":44}]