[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Implantica CE Reflux Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,62],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100593284","a-post-market-registry-to-assess-safety-and-performance-of-refluxstop-in-the-treatment-of-gerd-in-general-hospital-practice-100593284",false,"NCT07004439","A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice","A Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice","RESTORE500","Inclusion Criteria:\n\n1. Willing and able to provide informed consent and to participate in the registry study;\n2. Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;\n3. Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;\n4. 24-hour pH or impedance pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be \\\u003C 4 for ≥ 4.5% of total time during a 24-hour monitoring) and\u002For total reflux episodes \\>55 or weekly acid \\>26 for \\> 5 seconds, all measured 5 cm above LES);\n5. Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.\n\nExclusion Criteria:\n\n1. Hiatal Hernia larger than 8 cm;\n2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow\n3. History of bariatric surgery wherein the stomach fundus has been extirpated;\n4. Female subjects who are pregnant;\n5. Known sensitivity or allergies to silicone materials;\n6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);\n7. Subjects that are unable to comply with the registry requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement).","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and\u002For new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD.\n\nFollowing surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.",[27],"Gastroesophageal Reflux Disease","NOT_YET_RECRUITING","2025-05-27",{"date":31,"type":32},"2025-06-04","ACTUAL",{"date":34,"type":21},"2025-09-15",{"date":36,"type":21},"2035-08-01",{"name":38,"class":39},"Implantica CE Reflux Ltd.","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100593281","a-blinded-randomized-clinical-study-of-refluxstop-compared-with-nissen-fundoplication-in-the-treatment-of-gerd-100593281","NCT07004400","A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD","A Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).","RENEW RCT","Inclusion Criteria:\n\n1. Willing and able to provide informed consent and to participate in the clinical investigation;\n2. Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;\n3. Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;\n4. 24-hour pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be \\\u003C 4 for ≥ 4.5% of time during a 24-hour monitoring);\n5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator\n\nExclusion Criteria:\n\n1. \\> 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;\n2. Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI \\\u003C300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP\\>15mmHg). Hypercontractability defined as DCI \\>8'000 or pressure \\>45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;\n3. History of bariatric or anti-reflux surgery;\n4. Female subjects who are pregnant or nursing;\n5. Known sensitivity or allergies to silicone materials;\n6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the clinical investigation procedure (as outlined in the IFU);\n7. Subjects that are unable to comply with the clinical investigation requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement);",{"count":50,"type":21},200,[24],"This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.",[54],"GERD (Gastroesophageal Reflux Disease)",{"date":31,"type":32},{"date":57,"type":21},"2025-08-01",{"date":59,"type":21},"2026-12-01",{"name":38,"class":39},4,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":71,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100506113","post-market-registry-for-the-evaluation-of-refluxstop-in-gerd-treatment-100506113","NCT05870163","Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment","A Post-market Registry Study to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice","Inclusion Criteria:\n\n1. Willing and able to provide informed consent and to participate in the registry study,\n2. Patient's age ≥ 18 years or according to local legal age of adulthood if older,\n3. Documented GERD present for \\> 6 months,\n4. Patient has a 24-hour pH monitoring proven GERD with pH and\u002For impedance pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be \\\u003C4 for \\>4.5% of time during a 24-hour monitoring and\u002For total reflux episodes of acid \\>55 or weakly acid \\>26 for \\>5 seconds at 5 cm above LES)\n5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.\n\nExclusion criteria:\n\n1. Presence of para-esophageal hernia or sliding hernia \\> 3 centimeters,\n2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,\n3. History of bariatric surgery wherein the stomach fundus has been extirpated,\n4. Female patients who are pregnant or nursing,\n5. Known sensitivity or allergies to silicone materials,\n6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);\n7. Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).",{"count":70,"type":21},2500,"5 Years","OBSERVATIONAL","This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.",[75],"Gastroesophageal Reflux Disease (GERD)","RECRUITING","2025-03-26",{"date":79,"type":32},"2025-04-01",{"date":81,"type":32},"2023-02-20",{"date":83,"type":21},"2029-12-31",{"name":38,"class":39},6,""]