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MD","215-955-5869","Jennifer.MillerOcuin@jefferson.edu",{"name":156,"role":24,"phone":11,"phoneExt":11,"email":11},{"facility":161,"status":100,"city":162,"state":163,"zip":164,"country":38,"countryCode":39,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"University of Washington Medical Center","Seattle","Washington","98195",{"type":41,"coordinates":166},[167,168],-122.33207,47.60621,{"lat":168,"lon":167},[171,175],{"name":172,"role":28,"phone":173,"phoneExt":11,"email":174},"Adam Templeton, MD","206-598-4377","ATempleton@medicine.washington.edu",{"name":172,"role":24,"phone":11,"phoneExt":11,"email":11},{"facility":177,"status":100,"city":178,"state":179,"zip":180,"country":38,"countryCode":39,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Marshall University Medical Center","Huntington","West Virginia","25701",{"type":41,"coordinates":182},[183,184],-82.44515,38.41925,{"lat":184,"lon":183},[187,191],{"name":188,"role":28,"phone":189,"phoneExt":11,"email":190},"Wesam Frandah, MD","304-691-1830","frandah@marshall.edu",{"name":188,"role":24,"phone":11,"phoneExt":11,"email":11},{"type":193,"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":205,"type":206},66,"ESTIMATED","INTERVENTIONAL",[209],"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.",[212,213],"Anastomotic Leaks","Hartmanns Stump Leakage","2026-08-20",{"date":216,"type":217},"2026-08-21","ACTUAL",{"date":219,"type":206},"2026-09",{"date":221,"type":206},"2028-12",{"name":5,"class":6},10]