[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-lesion":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":35,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100526334","paradigm---en-bloc-trial-with-the-endoquest-endoluminal-surgical-els-system-100526334",false,"NCT06133387","PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System","PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System","PARADIGM","Preoperative Inclusion Criteria:\n\n1. Subject is ≥22 years at the time of consent.\n2. Subject has a BMI ≤ 50 kg\u002Fm2.\n3. Subject has an ASA score of ≤ 3.\n4. Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy\u002Fflexible sigmoidoscopy.\n5. Subject has lesion ≤ 7 cm in size (dimension of greatest extent) and ≤ 75% of the colorectal circumference as assessed by the most recent colonoscopy\u002Fflexible sigmoidoscopy.\n6. Subject is eligible for standard endoscopic submucosal dissection.\n7. Subject agrees to participate in the study by giving signed informed consent.\n\nPreoperative Exclusion Criteria:\n\n1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.\n2. Subject has active left-sided inflammatory bowel disease.\n3. Subject has an untreated active infection at the time of the procedure.\n4. Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).\n5. Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).\n6. Subject is breastfeeding or pregnant or intends to become pregnant during the study.\n7. Subject is currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n8. Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable).\n9. Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.\n10. Subject is moderately or severely immunocompromised.\n11. In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.\n\nIntraoperative Exclusion Criteria (assessed with third-party endoscope):\n\n1. Inadequate bowel prep.\n2. Complex anatomical findings not feasible for an endoluminal approach.\n3. Anatomical narrowing distal to the lesion site.\n4. Lesion not located in the rectum or sigmoid colon.\n5. Lesion size \\>7 cm (dimension of greatest extent) or occupies \\>75% of the colorectal circumference.\n6. Lesion demonstrates characteristics indicative of invasive carcinoma, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer.\n\n   Intraoperative Exclusion Criteria (assessed with study device):\n7. In the opinion of the Investigator, the subject and\u002For subject anatomy is not suitable for study device use for any reason.\n8. Lesion location not accessible by the study device.","ALL","22 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.\n\nThe safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.",[27,28,29,30,31,32,33,34],"Colorectal Lesion","Colorectal Adenoma","Colorectal Polyp","Rectal Lesion","Rectal Adenoma","Rectal Polyp","Sigmoid; Lesion","Sigmoid Colon Polyp",[30,36],"Sigmoid Lesion","RECRUITING","2026-04-09",{"date":40,"type":41},"2026-04-14","ACTUAL",{"date":43,"type":41},"2025-05-13",{"date":45,"type":21},"2026-06",{"name":47,"class":48},"EndoQuest Robotics, Inc.","INDUSTRY",6,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100475848","suprasorb-cnpendo-used-for-negative-pressure-therapy-in-the-oesophagus-and-rectum-to-support-defect-and-wound-healing-100475848","NCT05476263","Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing","Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population","Velox","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)\n* Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines\n* Signed informed consent for usage of data\n\nExclusion Criteria:\n\n* Pre-existing coagulation disorders with increased risk of bleeding\n* Defects involving the bronchial system (bronchus\u002Ftrachea\u002Fpulmo)\n* Any foreseeable deviation from IFU of Suprasorb® CNP endo\n* Known intolerance or allergy to one or more components of Suprasorb® CNPendo","18 Years",{"count":60,"type":21},110,"3 Months","OBSERVATIONAL","A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.\n\nPatients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.\n\nThe study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.",[65,30],"Esophagus Injury","2025-09-11",{"date":68,"type":41},"2025-09-12",{"date":70,"type":41},"2024-06-03",{"date":72,"type":21},"2027-09",{"name":74,"class":48},"Lohmann & Rauscher",7]