[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endoscopic-submucosal-dissection-esd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endoscopic-submucosal-dissection-esd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,70,98,125],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100631012","the-improvement-effect-of-real-time-artificial-intelligence-assisted-identification-of-bleeding-points-on-hemostasis-efficiency-in-endoscopic-submucosal-dissection-100631012",false,"NCT07495137","The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection","The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection (ESD): a Multicenter, Randomized Controlled Trial","Inclusion Criteria\n\n1. Aged 18-80 years;\n2. Lesions meet the indications for ESD treatment of the esophagus, stomach, or colorectum according to relevant guidelines;\n3. Anticoagulant drugs have been suspended according to relevant guidelines;\n4. Patients with American Society of Anesthesiologists (ASA) classification Grade I or II;\n5. Patients who voluntarily sign the informed consent form.\n\nExclusion Criteria\n\n1. Patients with severe cardiopulmonary diseases, coagulation dysfunction or other severe comorbidities that may increase surgical risks;\n2. Patients undergoing dialysis treatment;\n3. Pregnant or lactating women;\n4. Deemed unsuitable for participation in this study by the principal investigator or other researchers.","ALL","18 Years","80 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. It will also learn about the AI system's effect on surgery-related problems (like perforation or delayed bleeding) and total surgery time.\n\nThe main questions it aims to answer are:\n\n1. Does the AI system shorten the time it takes to stop each bleed during ESD?\n2. How does the AI system affect the rate of surgery-related problems and total surgery time?\n\nResearchers will compare two groups to see if the AI system improves hemostasis efficiency:\n\n1. AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding.\n2. Control group: Doctors will use the same equipment but without the AI system - they will find and stop bleeding using their own experience.\n\nParticipants will:\n\n1. Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment;\n2. Be randomly assigned to either the AI group or the control group;\n3. Attend follow-up checks in 14 days after surgery to check for complications;\n4. Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.",[27,28],"Endoscopic Submucosal Dissection","Endoscopic Submucosal Dissection (ESD)",[30,31],"Endoscopic submucosal dissection","Artificial intelligence","NOT_YET_RECRUITING","2026-03-22",{"date":35,"type":36},"2026-03-27","ACTUAL",{"date":38,"type":21},"2026-03-31",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Qilu Hospital of Shandong University","OTHER",{"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":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":4},"100621120","efficacy-and-safety-of-the-rdi-mode-in-endoscopic-submucosal-dissection-100621120","NCT07366489","Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection","Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection: a Multicenter, Randomized Controlled Study","RM-ESD","Inclusion Criteria:\n\n* Age ≥ 18 years.\n\n  * Early gastric cancer or precancerous lesions, early esophageal cancer or precancerous lesions, or early colorectal cancer\u002Fpolyps that meet ESD indications.\n\n    * ESD procedure to be performed at a participating center.\n\n      * Lesion diameter 20-60 mm. ⑤ Written informed consent provided voluntarily.\n\nExclusion Criteria:\n\n① Foreigners.\n\n② Severe coagulopathy (platelet count \\\u003C50×10⁹\u002FL or INR \\>1.5), significant cardiopulmonary disease, or any other contraindication to endoscopic therapy.\n\n③ Imaging evidence of distant metastasis or lymph-node metastasis.",{"count":53,"type":21},158,[24],"Conventional white-light endoscopy (WLE) is hampered by insufficient contrast when attempting to identify deep vessels and active bleeding sites; visibility drops further when blood pools or spurts obscure the field, resulting in significantly lower hemostatic efficiency. Red dichromatic imaging (RDI), a novel image-enhanced endoscopic modality, has recently been shown to improve the visualization of deep-lying vessels and bleeding points, shorten hemostasis time and potentially increase overall procedural efficiency.\n\nAlthough retrospective series have suggested that RDI may facilitate intra-operative bleeding control and better delineation of the submucosal plane during endoscopic submucosal dissection (ESD), high-level evidence from multicenter, randomized, controlled trials (RCTs) is lacking. No study has yet demonstrated superiority over WLE with respect to critical endpoints such as en-bloc resection rate, procedure time, complication rate and operator mental workload.\n\nThe investigators therefore designed a multicenter RCT to systematically compare the efficacy and safety of full-procedural RDI with conventional WLE during ESD.\n\nThe primary outcome parameter is the mean resection speed (mm²\u002Fmin) achieved with RDI versus conventional white-light endoscopy during ESD.\n\nThe secondary outcome parameters are: complete resection (R0) rate, en-bloc resection rate, resection margin, number of intra-procedural bleeding episodes, intra-procedural blood loss, intra-procedural hemostasis time, other intra-procedural adverse events, and post-procedural adverse events.",[28],[58,59,60,61],"ESD","RDI","early cancer","polyp","2026-01-16",{"date":64,"type":36},"2026-01-26",{"date":66,"type":21},"2026-01-01",{"date":40,"type":21},{"name":69,"class":43},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100620226","effect-of-simplified-robot-faster-assisted-versus-conventional-endoscopic-submucosal-dissection-esd-for-colorectal-lesions-100620226","NCT07354867","Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions","Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Patients with colorectal lesions scheduled to undergo endoscopic submucosal dissection (ESD)\n3. Lesion characteristics meeting any of the following criteria: (1) Lesions unsuitable for en bloc resection using snare-based EMR, including non-granular type laterally spreading tumors (LST-NG), especially pseudo-depressed subtype (PD); lesions with type VI pit pattern (VI-type glandular opening configuration); carcinomas with superficial submucosal invasion (T1-SM); large depressed-type tumors; large protruding lesions suspected of malignancy, including nodular mixed-type granular LSTs (LST-G); other lesions unsuitable for en bloc resection using snare-based EMR; (2) Lesions with special background conditions, including mucosal tumors with submucosal fibrosis (caused by prior biopsy or mucosal prolapse due to peristalsis); sporadic tumors arising in the context of chronic inflammation (e.g., ulcerative colitis); local residual or recurrent early carcinoma following prior endoscopic resection;\n4. Willingness to participate in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Suspected deep submucosal invasive carcinoma based on endoscopic features；\n2. Lesions presenting with non-lifting signs, suggesting deep submucosal invasive carcinoma or tumors with severe submucosal fibrosis;\n3. Lesions extending to the appendiceal orifice, colonic diverticulum, or ileocecal valve; (4) Pregnant women or women who may be pregnant; lactating women;\n4. Pregnant women or women who may be pregnant; lactating women;\n5. Patients with coagulation disorders;\n6. Patients considered ineligible for specific reasons;\n7. Patients with contraindications to anesthesia and\u002For colonoscopy. -",{"count":78,"type":21},40,[24],"This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.",[82,28,83],"Colorectal Lesions","FASTER Robot",[28,85,86,87,88],"Colorectal lesions","FASTER robot","Procedure time","Randomized controlled trial (RCT)","2026-01-12",{"date":91,"type":36},"2026-01-21",{"date":93,"type":21},"2026-01-06",{"date":95,"type":21},"2026-11-30",{"name":97,"class":43},"Kaiyun Liu",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100617228","endoscopic-full-thickness-suturing-of-mucosal-submucosal-and-perforation-defects-using-su2ura-gi-system-100617228","NCT07315893","Endoscopic Full Thickness Suturing of Mucosal, Submucosal and Perforation Defects Using Su2ura® GI System","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patient is able to provide informed consent .\n3. Body mass index (BMI) 20-40 kg\u002Fm2\n4. Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of a gastric neoplastic lesion\n5. Candidate for endoscopic defect closure based on the operating's endoscopist assessment.\n\nExclusion Criteria:\n\n1. Patient with severe comorbidities likely to limit survival to less than 2 years.\n2. Patients with INR\\>1.5\n3. Patients with PLT\\\u003C 150\n4. Patient with known collagen or connective tissue disorders (e.g. scleroderma, marfan syndrome) .\n5. Pregnant women or those intending to become pregnant during the study period\n6. Patient with ascites on physical examination or CT scan.\n7. Patient with varices.\n8. Patient on peritoneal dialysis.\n9. Patient with wound-healing disorders.\n10. Patient with significant coagulation disorders or those requiring anti thrombotic or anticoagulation treatment other than aspirin .\n11. Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily .\n12. Patients in need of immunomodulatory therapy.\n13. Immunocompromised patients (e.g., HIV\u002FAIDS, organ transplant, chemo- or radiation therapy 6 months prior to recruitment).\n14. Patient in need of concomitant surgical procedures other than those permitted in the protocol.\n15. Non-compliance with the study protocol.\n16. Patient requests to exist the study. -",{"count":105,"type":21},25,[24],"The objective of this clinical study is to assess the safety of the Su2ura® GI system when used for endoscopic suturing and soft-tissue approximation in patients referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions.\n\nThe main questions it aims to answer are:\n\n1. Percentage of patients with incomplete closure.\n2. Percentage of patients bleeding at closure site within 28 days from procedure.\n3. Percentage of patients with infection at closure site within 28 days from procedure.\n4. Percentage of patients with leakage within 72 hours from procedure.\n5. Serious Adverse Device Effects (SADE) within 28 days from procedure.\n6. Overall rates of Adverse Device Effect within 28 days from procedure.\n\nStudy includes 6 visits: Screening, Baseline\u002FSurgery, Discharge and 4 weeks, 3 months and 6 months post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 6.5 months.\n\nThe patient will be admitted to the medical center on the day of the procedure or one day prior for preoperative preparation. Following tissue resection using one of the methods (ESD or EMR), suturing will be performed using the Su2ura® GI system.\n\nPostoperatively, the patient will be transferred to the recovery area and then to the surgical ward for standard monitoring, with an expected one-night postoperative stay and discharge the following day.\n\nStudy follow-up visits will take place 4 weeks, 3 and 6 months post surgery.",[109,28],"Endoscopic Mucosal Resection",[111,112,113],"endoscopic mucosal resection (EMR)","endoscopic submucosal dissection (ESD)","a gastric neoplastic lesion","RECRUITING","2026-01-04",{"date":117,"type":36},"2026-01-07",{"date":119,"type":36},"2025-08-18",{"date":121,"type":21},"2026-12-31",{"name":123,"class":43},"Anchora Medical",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":124},"100590873","efficacy-and-safety-of-robot-assisted-endoscopic-submucosal-dissection-for-colorectal-neoplasm-100590873","NCT06973083","Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm","Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A Randomized Controlled Trial.","Inclusion Criteria:\n\n* Patients aged 18-85.\n* Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.\n\nExclusion Criteria:\n\n* Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis or other conditions that are not suitable for endoscopic therapy.\n* Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.\n* Patients have a history of colorectal malignancy with previous radiotherapy or operative treatment leading to changes in colorectal structure.\n* Patients have lesions with local recurrence after endoscopic resection.\n* Patients unable to obtain informed consent.","85 Years",{"count":134,"type":21},104,[24],"The objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system in colorectal endoscopic submucosal dissection (ESD) and to validate its superiority over conventional ESD in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety.\n\nThe main questions it aims to answer are:\n\nDoes the use of the FASTER system improve the dissection speed of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Does the use of the FASTER system reduce the rate of perforation and hemorrhage, improving the safety of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.\n\nParticipants will:\n\nBe randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.\n\nKeep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. However, ESD is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. The inherent challenges of the colorectal ESD are further amplified by the thin mucosa, highly tortuous and flexible lumen, and occasional obstruction of lesions by mucosal folds, all of which collectively elevate both the procedural difficulty and the probability of postoperative complications. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.",[138,28,139],"Robot Surgery","Colorectal Neoplasms","2025-05-16",{"date":142,"type":36},"2025-05-21",{"date":144,"type":21},"2025-06-01",{"date":146,"type":21},"2026-12-30",{"name":148,"class":43},"Shandong University"]