NCT07035431 · Boston Scientific Corporation
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
(DRAIN Lower)
What this study is about
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 forward-looking multi-center study.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Orlando, Florida
- Weston, Florida
- Burlington, Massachusetts
- New York, New York
- Cleveland, Ohio
- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Seattle, Washington
- Huntington, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations