Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
DRAIN Lower
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
1 other identifier
interventional
66
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 7, 2026
May 1, 2026
2.6 years
June 10, 2025
May 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Serious Adverse Events
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.
Day 0 Study Procedure to end of study; up to 6 months
Clinical Success
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.
Day 0 Study Procedure to the last study device removal; up to 3 months
Secondary Outcomes (8)
Technical Success
Day 0 Study Procedure to the last study device exchange; up to 3 months
Closure Time
Day 0 Study Procedure to the last study device removal; up to 3 months
Rate of Reinterventions
From last study device removal to end of study; 3 months
Time to Additional Intervention
Day 0 Study Procedure to the last study device removal; up to 3 months
Leak Recurrence
From last study device removal to end of study; 3 months
- +3 more secondary outcomes
Study Arms (1)
Endoscopic Vacuum Therapy (EVT) Device
EXPERIMENTALInterventions
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Mount Sinai
New York, New York, 10029, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Penn State Health
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Marshall University Medical Center
Huntington, West Virginia, 25701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Pauli, MD
Penn State Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 25, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share