[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566937":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Evangelic Hospital Kalk Cologne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gastroparesis group",null,"Patients scintigraphically proven gastroparesis and failed conservative therapy who undergo laparoscopic gastric pacemaker implantation",[13],"Device: Gastric pacemaker (Enterra system) implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Gastric pacemaker (Enterra system) implantation","Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis",[9],[21],{"name":22,"affiliation":23,"role":24},"Jessica M Leers, Prof.","Department of Functional Upper GI Surgery","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","+49 221","82892800","jessica.leers@uk-koeln.de",[32],{"facility":23,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Cologne","North Rhine-Westphalia","51103","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],6.95,50.93333,{"lat":43,"lon":42},[46],{"name":22,"role":27,"phone":47,"phoneExt":10,"email":30},"0221-82892800",{"type":24,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":51,"oldNameTitle":10,"oldOrganization":10},"Jessica Leers","Prof. Dr. med. Jessica Leers","University of Cologne",[53],{"name":54,"class":55},"Enterra Medical, Inc.","INDUSTRY","100566937","laparoscopic-implantation-of-a-gastric-pacemaker-in-the-treatment-of-gastroparesis-100566937",false,"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","ALL","18 Years",{"count":66,"type":67},50,"ESTIMATED","5 Years","OBSERVATIONAL","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.",[72,73,74,75],"Gastroparesis","Gastroparesis Postoperative","Gastroparesis Nondiabetic","Gastroparesis With Diabetes Mellitus",[72,77],"Gastric pacemaker","2025-08-06",{"date":80,"type":81},"2025-08-12","ACTUAL",{"date":83,"type":81},"2023-01-01",{"date":85,"type":67},"2026-12-31",{"name":5,"class":6},1]