[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hartmanns-stump-leakage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hartmanns-stump-leakage":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100595667",false,"NCT07035431","Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area","A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the Lower Pelvic Area","DRAIN Lower","Inclusion Criteria:\n\n* Confirmed grade B anastomotic leak as per the ISGRC (International Study Group of Rectal Cancer) grading system after colorectal surgery.\n* Subject is eligible for endoscopic intervention.\n* Subject has a transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area.\n* Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity.\n* Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement.\n* Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study.\n* Investigator decision that EVT is the most suitable treatment of the available treatment options.\n\nExclusion Criteria:\n\n* Subject is under 18 years of age.\n* Potentially vulnerable subject, including, but not limited to pregnant women.\n* Subject has undergone EVT or other similar interventions for the current colorectal indication.\n* Subject had colorectal surgery more than 60 days prior to the planned study procedure.\n* Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement.\n* Subject has known contraindication for EVT as per the IB.\n* Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal surgery in a prospective multi-center study.",[26,27],"Anastomotic Leaks","Hartmanns Stump Leakage","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":20},"2026-07",{"date":36,"type":20},"2028-12",{"name":38,"class":39},"Boston Scientific Corporation","INDUSTRY",9,""]