Endo-SPONGE treatment for lower pelvic anastomotic or Hartmann's stump leakages

A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Endo-SPONGE for the Treatment of Anastomotic or Hartmann's Stump Leakages in the Lower Pelvic Area

This study will test whether Endo-SPONGE endoscopic vacuum therapy can safely help close anastomotic or Hartmann's stump leakages in adults after colorectal surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boston Scientific Corporation (Industry-sponsored)
• Locations: 8 sites (Orlando, Florida and 7 other locations)
• Trial ID: NCT07035431 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter interventional study using sponge-based endoscopic vacuum therapy (Endo-SPONGE) to treat anastomotic or Hartmann's stump leakages in the lower pelvic area. Adults with confirmed grade B leaks, an extraperitoneal transmural defect of at least 2 cm, and a diverting ostomy are eligible and will undergo endoscopic placement of the sponge with serial exchanges until defect closure. The study will collect safety data and effectiveness outcomes such as leak closure rate, time to closure, and procedure-related adverse events. Procedures are performed at participating US centers with protocol-defined follow-up visits to document healing and complications.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed grade B anastomotic or Hartmann's stump leak in the extraperitoneal lower pelvis, a transmural defect ≥2 cm, an existing or newly created diverting ostomy, and who are eligible for endoscopic intervention.

Not a fit: Patients under 18, pregnant or otherwise vulnerable individuals, those with leaks outside the extraperitoneal lower pelvis, defects smaller than 2 cm, or who are not candidates for endoscopic therapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive option to close pelvic anastomotic or stump leaks, potentially avoiding additional major surgery and shortening recovery.

How similar studies have performed: Previous case series and cohort studies of endoscopic vacuum therapy and Endo-SPONGE have reported promising healing rates and safety, but randomized and large multicenter data remain limited.

Eligibility criteria

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.

Where this trial is running

Orlando, Florida and 7 other locations

• Orlando Regional Medical Center — Orlando, Florida, United States (Not_yet_recruiting)
• Cleveland Clinic Florida — Weston, Florida, United States (Not_yet_recruiting)
• Mount Sinai — New York, New York, United States (Not_yet_recruiting)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (Not_yet_recruiting)
• Penn State Health — Hershey, Pennsylvania, United States (Not_yet_recruiting)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
• Marshall University Medical Center — Huntington, West Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Eric Pauli, MD — Penn State Health
• Study coordinator: Steve Fodem

Conditions Anastomotic Leaks; Hartmanns Stump Leakage