[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Evangelic Hospital Kalk Cologne\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},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.",[25,26,27,28],"Gastroparesis","Gastroparesis Postoperative","Gastroparesis Nondiabetic","Gastroparesis With Diabetes Mellitus",[25,30],"Gastric pacemaker","RECRUITING","2025-08-06",{"date":34,"type":35},"2025-08-12","ACTUAL",{"date":37,"type":35},"2023-01-01",{"date":39,"type":20},"2026-12-31",{"name":41,"class":42},"Evangelic Hospital Kalk Cologne","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100562008","prospective-kln-bonn-registry-for-the-extraction-of-pacmaker-and-icd-leads-100562008","NCT06597578","Prospective Köln Bonn Registry for the Extraction of Pacmaker and ICD Leads","Prospektives KÖln Bonner Register Zur Extraktion Von Schrittmacher- Und ICD-Sonden (KÖBES)","KOBES","Inclusion Criteria:\n\n* All patients with a standard indication for lead extraction according to the HRS \u002F EHRA guidelines\n\nExclusion Criteria:\n\n* None",{"count":53,"type":20},200,"1 Year","The KOBES registry is an all-comers prospective clinical registry of the cooperative Köln Bonn lead extraction center. All patients undergoing complex lead extraction procedures (i.e. indwelling leads \\> 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. Preoperative, intraoperative\u002Fprocedural and postoperative parameters will be recorded. All patients will be asked to provide written informed consent. Data will be pseudonomyzed and entered into a data sheet. Data will be monitored by a board and evaluated independently.",[57,58,59],"Infections","Pacemaker, Artificial","Defibrillators, Implantable",[61,62,63,64,65,66,67],"lead extraction","cardiac device","infection","complication","pacemaker","implantable cardioverter-defibrillator","extraction tools","2024-09-13",{"date":70,"type":35},"2024-09-19",{"date":72,"type":35},"2023-06-04",{"date":74,"type":20},"2027-12-31",{"name":41,"class":42},""]