Recruiting

Endo-SPONGE

Sponsor:

Boston Scientific Corporation

Code:

NCT07035431

Conditions

Anastomotic Leaks

Hartmanns Stump Leakage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endo-SPONGE

Study Details

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.

Conditions

Anastomotic Leaks

Hartmanns Stump Leakage

Study ID

NCT07035431

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

66 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Endoscopic Vacuum Therapy (EVT) Device

Interventions

Endo-SPONGE

The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.

Primary outcome measure

  • Serious Adverse Events [ Time Frame: Day 0 Study Procedure to end of study; up to 6 months ]
  • Clinical Success [ Time Frame: Day 0 Study Procedure to the last study device removal; up to 3 months ]

Central Contacts and Locations

Central contacts

Steve Fodem

651-246-3094Steve.Fodem@bsci.com

Locations

Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Patricia Sylla

212-241-3547patricia.sylla@mountsinai.org

Principal Investigator:

Patricia Sylla, MD

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Eric Pauli, MD

717-531-7462epauli@pennstatehealth.psu.edu

Principal Investigator:

Eric Pauli, MD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Adam Templeton, MD

206-598-4377ATempleton@medicine.washington.edu

Principal Investigator:

Adam Templeton, MD

Marshall University Medical Center

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Wesam Frandah, MD

304-691-1830frandah@marshall.edu

Principal Investigator:

Wesam Frandah, MD

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-21.