[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroparesis-nondiabetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroparesis-nondiabetic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,70,96,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642902","effect-of-gastric-electrical-stimulation-on-serum-insulin-levels-100642902",false,"NCT07635576","Effect of Gastric Electrical Stimulation on Serum Insulin Levels","Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects","Inclusion Criteria:\n\n* • At least 18 years of age.\n\n  * Documented diagnosis of gastroparesis\n  * Not taking diabetic prescribed exogenous insulin.\n  * Patient has a GES device that has been implanted for at least 3 months.\n  * Willing to give up to 8 blood samples.\n  * Willing to lie in a bed for up to 5.5 hours.\n\nExclusion Criteria:\n\n* • Pregnancy\n\n  * History of allergic reaction to EKG lead placement adhesives.\n  * Unable to give informed consent.\n  * Unwilling to give up to 8 5 ml blood samples.\n  * Unwilling to lie in a bed for up to 5.5 hours.","ALL","18 Years","70 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this observational study is to determine how much effect turning the subject's Gastric Electrical Stimulator off for up to four hours will have on levels of insulin, C-peptide, GLP-1 and Glucose levels in patients with gastroparesis who have had a GES for at least three months, who are not taking diabetic prescribed exogenous insulin. EKG recordings will be made and analyzed for Heart Rate Variability and Power Spectral Analysis.",[27],"Gastroparesis Nondiabetic","RECRUITING","2026-06-03",{"date":31,"type":32},"2026-06-09","ACTUAL",{"date":34,"type":21},"2026-06-08",{"date":36,"type":21},"2030-09-30",{"name":38,"class":39},"Indiana University","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100504322","gastroparesis-registry-4-100504322","NCT05846802","Gastroparesis Registry 4","Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia","GpR4","Inclusion Criteria:\n\n* Age at least 18 years at initial screening visit\n* Symptoms of Gp and\u002For FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.\n* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months\n* Negative upper endoscopy or upper radiographic GI series within 5 years of registration\n\nExclusion Criteria:\n\n* Use of narcotic analgesics greater than three days per week\n* Presence of other conditions that could explain the patient's symptoms such as:\n* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT\n* Active inflammatory bowel disease\n* Known eosinophilic gastroenteritis or eosinophilic esophagitis\n* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory\u002Finfectious lesions\n* Acute or chronic renal failure (serum creatinine \\>3 mg\u002FdL) and\u002For on hemodialysis or peritoneal dialysis\n* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)\n* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing\n* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)\n* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements\n* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.\n* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)\n* Inability to obtain informed consent","85 Years",{"count":51,"type":21},250,"OBSERVATIONAL","The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.",[55,27,56,57,58,59],"Gastroparesis","Gastroparesis Due to Diabetes Mellitus Type I","Gastroparesis Due to Diabetes Mellitus Type II","Functional Disorder of Gastrointestinal Tract","Gastro-Intestinal Disorder","2026-03-30",{"date":62,"type":32},"2026-04-03",{"date":64,"type":32},"2024-09-20",{"date":66,"type":21},"2027-04-30",{"name":68,"class":39},"Johns Hopkins Bloomberg School of Public Health",6,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":79,"studyType":52,"phases":4,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100566937","laparoscopic-implantation-of-a-gastric-pacemaker-in-the-treatment-of-gastroparesis-100566937","NCT06661668","Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis","Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis","Inclusion Criteria:\n\n* Scintigraphically proven gastroparesis\n* Failed conservative therapy\n* Severe impairment of quality of life\n* Written informed consent\n* German language\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Prior gastric resection",{"count":78,"type":21},50,"5 Years","Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.\n\nImplantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.\n\nAim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.",[55,82,27,83],"Gastroparesis Postoperative","Gastroparesis With Diabetes Mellitus",[55,85],"Gastric pacemaker","2025-08-06",{"date":88,"type":32},"2025-08-12",{"date":90,"type":32},"2023-01-01",{"date":92,"type":21},"2026-12-31",{"name":94,"class":39},"Evangelic Hospital Kalk Cologne",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":69},"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",{"count":78,"type":21},[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.",[55,27,108],"Gastroparesis Due to Diabetes Mellitus",[110,55],"Gastric electrical stimulation","2024-11-13",{"date":113,"type":32},"2024-11-15",{"date":115,"type":32},"2024-07-25",{"date":117,"type":21},"2026-12",{"name":119,"class":120},"Enterra Medical, Inc.","INDUSTRY",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":40},"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":78,"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.",[55,27,108],[110,55],{"date":113,"type":32},{"date":136,"type":32},"2023-07-10",{"date":138,"type":21},"2025-12",{"name":119,"class":120}]