[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fundoplication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fundoplication":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100635715","phase-2-transoral-incisional-fundoplication-tif-for-patients-suffering-from-gastroesophageal-reflux-disease-in-an-asian-population-100635715",false,"NCT07556289","Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population","Inclusion Criteria:\n\n* 18 years - 80 years of age\n* More than 6 months of GERD symptoms and troublesome regurgitation, despite a minimum PPI dose of 40 mg daily. Troublesome regurgitation was defined as mild symptoms for 2 or more days per week or moderate to severe symptoms more than 1 day per week, per Montreal consensus criteria. Patients will be followed-up for 5 years.\n* Symptom assessment used the following 3 validated tools: the Reflux Disease Questionnaire (RDQ), and the GERD-QOL score on PPI and off PPI for at least 7 days.\n* Abnormal amounts of gastroesophageal reflux off PPI for 7 days was confirmed by distal esophageal pH \\\u003C4 for \\>5.3% of at least 1 of the 2 days that pH was measured with a Bravo (radiotelemetry) probe (Given Imaging, Yoqneam, Israel).\n\nExclusion Criteria:\n\n* Systemic disease not well controlled\n* Obesity determined by body mass index \\>35\n* Esophageal ulcer, stricture\n* Barrett's esophagus \\>2 cm in length\n* Hiatal hernia \\>2 cm in length\n* Los Angeles grade C or D esophagitis\n* Peptic ulcer disease\n* Gastroparesis\n* Pregnancy or plans for pregnancy in the next 12 months\n* Immunosuppression\n* Portal hypertension\n* Coagulopathy","ALL","18 Years","80 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The technique offers an acceptable alternative to surgery, mimicking partial fundoplication, but less invasive and with no persistent side effects, in patients with proven pathological GERD with either a competent gastroesophageal valve or hiatal hernia, not longer than 3cm, who refuse, are intolerance, or are unresponsive to PPI maintenance therapy. Laparoscopic fundoplication, although still considered to be the gold-standard approach for GERD refractory to medical treatment, does involve some risk of long-term adverse events such as dysphagia (5-12%), inability to vomit or belch, gas\u002Fbloat syndrome (19%) and excessive flatulence.\n\nSeveral prospective observational studies and some comparative trials have proved efficacy of TIF with EsophyX in obtaining a significant reduction in the acid exposure time (AET) assessed by esophageal 24-hour pH-impedance monitoring versus sham, and in controlling both typical and atypical GERD symptoms for up to 1 to 2 years, as reported in a meta-analysis7. Outcomes at 3, 5, and 10 years have been reported in different studies and showed to be favourable. In an Italian study reporting the 10 year follow-up, the GERD-HRQL score, heartburn and regurgitation score were significantly lower than pre-procedure and did not change significantly during the follow-up. The rates of patients who had stopped or halved anti-secretive therapy 2, 3, 5, 7 and 10 years after the procedure were 86.7%, 84.4%, 73.5%, 83.3% and 91.7% respectively.\n\nThis procedure, however, has not been performed in Asia patients. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population.\n\nIn patients who fulfil the inclusion criteria, TIF will be performe under general anaesthesia. They will then be followed-up at 4 weeks, 3 months, then yearly for up to 5 years after the procedure. The anti-reflux control and adverse events will be recorded.",[26,27],"Fundoplication","GERD",[26,27],"RECRUITING","2026-04-22",{"date":32,"type":33},"2026-04-29","ACTUAL",{"date":35,"type":33},"2021-08-01",{"date":37,"type":20},"2026-08-01",{"name":39,"class":40},"Chinese University of Hong Kong","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100633703","clinical-trial-on-safety-and-efficacy-of-thoracoabdominal-endoscopic-surgical-system-for-pediatric-surgery-100633703","NCT07530133","Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery","Prospective, Multicenter, Single-arm Target-value Clinical Trial Evaluating the Safety and Efficacy of Thoracoabdominal Endoscopic Surgical Systems in Pediatric Surgery","Inclusion Criteria:\n\n* Aged 0 to 18 years old (excluding 18 years old), gender is not restricted.\n* Subjects with indications for pediatric thoracic and abdominal laparoscopic surgery and medically fit for laparoscopic procedures.\n* Legally authorized representative provides written informed consent; subject assent is obtained when the subject is developmentally capable.\n\nExclusion Criteria:\n\n* Previous laparoscopic or open surgery at the target site, deemed unsuitable for laparoscopic surgery by the investigator.\n* Thoracic\u002Fabdominal\u002Fpelvic infection, peritonitis, diaphragmatic hernia, or severe systemic infection, deemed unsuitable for laparoscopic surgery.\n* Severe bleeding tendency or coagulopathy (APTT \\> 1.5× upper limit of normal); long-term use of anticoagulants or antiplatelet agents, or such medications not discontinued for at least 1 week preoperatively (prophylactic low-molecular-weight heparin excluded).\n* Severe cardiovascular or circulatory disease incompatible with surgery.\n* Epilepsy or cognitive impairment.\n* Suspected or confirmed drug addiction.\n* Pregnancy.\n* Participation in another interventional device clinical trial within 1 month or a drug clinical trial within 3 months prior to enrollment.\n* Intraoperative findings that preclude laparoscopic surgery (e.g., severe adhesions, anatomical variation, poor exposure).\n* Other conditions deemed unsuitable by the investigator.","0 Years","17 Years",{"count":52,"type":20},64,[54],"NA","This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical procedures. A total of 64 pediatric subjects aged 0 to \\\u003C18 years who meet the indications for thoracic and abdominal laparoscopic surgery will be enrolled. The system is used to perform typical pediatric surgeries including pyeloplasty, ureteral reimplantation, ovarian tumor resection, radical resection of Hirschsprung disease, fundoplication, segmental lung resection, and choledochal cyst resection. The primary efficacy endpoint is the rate of non-conversion to open or conventional laparoscopic surgery.The primary safety endpoint is the incidence of device-related or possibly related Clavien-Dindo Grade ≥3 complications from the first incision up to 30 days postoperatively. Secondary assessments include operation time, estimated intraoperative blood loss, pediatric pain scores, transfusion rate, length of hospital stay, device performance, and surgeon intraoperative physical load. Safety is also evaluated by overall complication rate, device deficiency rate, 30-day readmission\u002Freoperation\u002Fmortality rates, vital signs, laboratory tests, and adverse events. The trial follows the Declaration of Helsinki and relevant Good Clinical Practice (GCP) guidelines. All subjects will provide written informed consent from legal guardians; assent will be obtained from subjects when appropriate.",[57,58,59,60,61,62,26,63,64],"Indications for Laparoscopic Thoracic and Abdominal Surgery in Children","Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children","Pyeloplasty","Ureteral Reimplantation","Ovarian Tumor Resection","Radical Operation for Hirschsprung Disease","Pulmonary Segmentectomy","Choledochal Cyst Resection",[66,67],"Pediatric surgery","Minimally invasive surgery","NOT_YET_RECRUITING","2026-04-08",{"date":71,"type":33},"2026-04-15",{"date":73,"type":20},"2026-04-09",{"date":75,"type":20},"2026-10-31",{"name":77,"class":78},"Hangzhou Kangji Weijing Medical Robotics Co., Ltd.","INDUSTRY",3]