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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Vacuum Therapy (EVT) Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endo-SPONGE | Device | The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 0 Study Procedure to the last study device removal; up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 Study Procedure to the last study device exchange; up to 3 months |
| Closure Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Fodem | Contact | 651-246-3094 | Steve.Fodem@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Eric Pauli, MD | Penn State Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Regional Medical Center | Not yet recruiting | Orlando | Florida | 32806 | United States |
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Time to colorectal anastomotic or Hartmann's stump leak closure. |
| 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. | 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. | Day 0 Study Procedure to the last study device removal; up to 3 months |
| Leak Recurrence | Leak recurrence within 3 months following completion of Endo-SPONGE therapy. | From last study device removal to end of study; 3 months |
| Endo-SPONGE Exchanges | Number of Endo-SPONGE exchanges needed to reach clinical success. | Day 0 Study Procedure to last study device removal; up to 3 months |
| Length of Hospitalization | Length of Hospitalization. | Day 0 Study Procedure to end of study; up to 6 months |
| Mortality Rate | Mortality rate through 3-month follow-up. | Day 0 Study Procedure to end of study; up to 6 months |
| Cleveland Clinic Florida | Not yet recruiting | Weston | Florida | 33331 | United States |
|
| Lahey Medical Center | Not yet recruiting | Burlington | Massachusetts | 01805 | United States |
|
| Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Cleveland Clinic Foundation | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
|
| Penn State Health | Not yet recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Thomas Jefferson University Hospital | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
|
| Marshall University Medical Center | Recruiting | Huntington | West Virginia | 25701 | United States |
|
| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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