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MD","304-691-1830","frandah@marshall.edu",{"name":173,"role":24,"phone":11,"phoneExt":11,"email":11},{"type":178,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100595667","endo-sponge-for-treatment-of-anastomotic-or-hartmanns-stump-leakages-in-lower-pelvic-area-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":190,"type":191},66,"ESTIMATED","INTERVENTIONAL",[194],"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.",[197,198],"Anastomotic Leaks","Hartmanns Stump Leakage","2026-06-17",{"date":201,"type":202},"2026-06-18","ACTUAL",{"date":204,"type":191},"2026-07",{"date":206,"type":191},"2028-12",{"name":5,"class":6},9]