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โ† Trials
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Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area

RecruitingNAAges 18 Years - anyAllBoston Scientific Corporation
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Confirmed grade B anastomotic leak as per the ISGRC (International Study Group of Rectal Cancer) grading system after colorectal surgery. * Subject is eligible for endoscopic intervention. * Subject has a transmural defect of at least 2 cm in diameter following colorectal surgery in the lower pelvic area. * Subject has an anastomotic or Hartmann's stump leak located within an extraperitoneal cavity. * Subject has pre-existing diverting ostomy or an ostomy created prior to the first Endo-SPONGE placement. * 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. * Investigator decision that EVT is the most suitable treatment of the available treatment options. Exclusion Criteria: * Subject is under 18 years of age. * Potentially vulnerable subject, including, but not limited to pregnant women. * Subject has undergone EVT or other similar interventions for the current colorectal indication. * Subject had colorectal surgery more than 60 days prior to the planned study procedure. * Subject has any necrotic tissue that would require endoscopic debridement prior to Endo-SPONGE placement. * Subject has known contraindication for EVT as per the IB. * Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
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What it tests

  • Endo-SPONGE
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Where

10 sites
University of California, Davis Medical Center
Sacramento, United States
Orlando Regional Medical Center
Orlando, United States
Cleveland Clinic Florida
Weston, United States
Lahey Medical Center
Burlington, United States
Mount Sinai
New York, United States
Cleveland Clinic Foundation
Cleveland, United States
Penn State Health
Hershey, United States
Thomas Jefferson University Hospital
Philadelphia, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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