Anastomotic Leaks, Hartmanns Stump Leakage
Conditions
Brief summary
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.
Interventions
DEVICEEndo-SPONGE
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Day 0 Study Procedure to end of study; up to 6 months | 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. |
| Clinical Success | Day 0 Study Procedure to the last study device removal; up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Day 0 Study Procedure to the last study device exchange; up to 3 months | 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. |
| Closure Time | Day 0 Study Procedure to the last study device removal; up to 3 months | Time to colorectal anastomotic or Hartmann's stump leak closure. |
| Rate of Reinterventions | From last study device removal to end of study; 3 months | Rate of Reinterventions after closure of the anastomotic or Hartmann's stump leak. |
| Time to Additional Intervention | Day 0 Study Procedure to the last study device removal; up to 3 months | Time to additional intervention, if Endo-SPONGE treatment is insufficient. |
| Leak Recurrence | From last study device removal to end of study; 3 months | Leak recurrence within 3 months following completion of Endo-SPONGE therapy. |
| Endo-SPONGE Exchanges | Day 0 Study Procedure to last study device removal; up to 3 months | Number of Endo-SPONGE exchanges needed to reach clinical success. |
| Length of Hospitalization | Day 0 Study Procedure to end of study; up to 6 months | Length of Hospitalization. |
| Mortality Rate | Day 0 Study Procedure to end of study; up to 6 months | Mortality rate through 3-month follow-up. |
Countries
United States
Contacts
CONTACTSteve Fodem
PRINCIPAL_INVESTIGATOREric Pauli, MD
Penn State Health
Outcome results
None listed