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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Cleveland Clinic Florida
Weston, Florida, United States
NOT_YET_RECRUITINGMount Sinai
New York, New York, United States
NOT_YET_RECRUITINGPenn State Health
Hershey, Pennsylvania, United States
Serious Adverse Events
The proportion of subjects with one or more study device or endoscopic or study procedure-related Serious Adverse Events (SAEs) occurring up to 3 months after the last study device removal.
Time frame: Day 0 Study Procedure to end of study; up to 6 months
Clinical Success
The proportion of subjects that demonstrate clinical success, which is defined as closure of the anastomotic or Hartmann's stump leak, confirmed via endoscopy or contrast-enhanced computed tomography imaging within 3 months after the study procedure without the need for an additional endoscopic or surgical intervention.
Time frame: Day 0 Study Procedure to the last study device removal; up to 3 months
Technical Success
Defined as the ability to deploy the Endo-SPONGE in the intended location. This will be calculated for study procedure and every Endo-SPONGE Exchange that is attempted.
Time frame: Day 0 Study Procedure to the last study device exchange; up to 3 months
Closure Time
Time to colorectal anastomotic or Hartmann's stump leak closure.
Time frame: Day 0 Study Procedure to the last study device removal; up to 3 months
Rate of Reinterventions
Rate of Reinterventions after closure of the anastomotic or Hartmann's stump leak.
Time frame: From last study device removal to end of study; 3 months
Time to Additional Intervention
Time to additional intervention, if Endo-SPONGE treatment is insufficient.
Time frame: Day 0 Study Procedure to the last study device removal; up to 3 months
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Washington Medical Center
Seattle, Washington, United States
RECRUITINGMarshall University Medical Center
Huntington, West Virginia, United States
RECRUITINGLeak Recurrence
Leak recurrence within 3 months following completion of Endo-SPONGE therapy.
Time frame: From last study device removal to end of study; 3 months
Endo-SPONGE Exchanges
Number of Endo-SPONGE exchanges needed to reach clinical success.
Time frame: Day 0 Study Procedure to last study device removal; up to 3 months
Length of Hospitalization
Length of Hospitalization.
Time frame: Day 0 Study Procedure to end of study; up to 6 months
Mortality Rate
Mortality rate through 3-month follow-up.
Time frame: Day 0 Study Procedure to end of study; up to 6 months