Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
NCT ID: NCT07035431
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2025-11-30
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endoscopic Vacuum Therapy (EVT) Device
Endo-SPONGE
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Interventions
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Endo-SPONGE
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Pauli, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State Health
Locations
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Barnes Jewish Hospital
St Louis, Missouri, United States
Mount Sinai
New York, New York, United States
New York Presbyterian / Columbia University Irving Medical Center
New York, New York, United States
Penn State Health
Hershey, Pennsylvania, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew Silviera, MD
Role: primary
Patricia Sylla
Role: primary
Kavel Visrodia, MD
Role: primary
Eric Pauli, MD
Role: primary
Adam Templeton, MD
Role: primary
Other Identifiers
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E7212
Identifier Type: -
Identifier Source: org_study_id