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

Not Applicable

Not yet recruiting

• Conditions: Anastomotic Leaks; Hartmanns Stump Leakage

• Registration Number: NCT07035431
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-12-01
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Ascension / St. John Hospital and Medical Center; 🇺🇸 Saint Clair Shores, Michigan, United States

Barnes Jewish Hospital; 🇺🇸 Saint 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

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Penn State Health; 🇺🇸 Hershey, Pennsylvania, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States