Anastomotic LeaksDRAIN LowerNCT07035431
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
A study testing Endo-SPONGE in people with Anastomotic Leaks and Hartmanns Stump Leakage, run by Boston Scientific Corporation at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leaks, Hartmanns Stump Leakage
- What is being tested?
- Endo-SPONGE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Not yet recruiting
Lahey Medical Center
Burlington, Massachusetts, 01805
Jonathan S Abelson, MD, 781-744-8990, jonathan.s.abelson@lahey.org
Jonathan S Abelson, MD
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Emre Gorgun, MD, 216-444-1244, gorgune@ccf.org
Emre Gorgun, MD
- Recruiting
Penn State Health
Hershey, Pennsylvania, 17033
Eric Pauli, MD, 717-531-7462, epauli@pennstatehealth.psu.edu
Eric Pauli, MD
- Recruiting
Marshall University Medical Center
Huntington, West Virginia, 25701
Wesam Frandah, MD, 304-691-1830, frandah@marshall.edu
Wesam Frandah, MD
- Recruiting
Mount Sinai
New York, New York, 10029
Patricia Sylla, 212-241-3547, patricia.sylla@mountsinai.org
Patricia Sylla, MD
- Not yet recruiting
Orlando Regional Medical Center
Orlando, Florida, 32806
Antonio Caycedo, MD, 407-422-3790, Antonio.Caycedo@orlandohealth.com
Antonio Caycedo, MD
- Not yet recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jennifer Miller, MD, 215-955-5869, Jennifer.MillerOcuin@jefferson.edu
Jennifer Miller, MD
- Not yet recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
Sean Flynn, MD, 916-734-2843, smflynn@health.ucdavis.edu
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Adam Templeton, MD, 206-598-4377, ATempleton@medicine.washington.edu
Adam Templeton, MD
- Not yet recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Marylise Boutros, MD, 954-659-5757, boutrom3@ccf.org
Marylise Boutros, MD
About this study
Official title: 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 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
- Being tested
- Endo-SPONGE
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-SPONGEDevice
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Vacuum Therapy (EVT) Device | Experimental | Not described Receives: Device: Endo-SPONGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 Study Procedure to the last study device removal; up to 3 months
Secondary outcomes (8)
Technical Success
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.
Measured: Day 0 Study Procedure to the last study device exchange; up to 3 months
Closure Time
Time to colorectal anastomotic or Hartmann's stump leak closure.
Measured: Day 0 Study Procedure to the last study device removal; up to 3 months
Rate of Reinterventions
Rate of Reinterventions after closure of the anastomotic or Hartmann's stump leak.
Measured: From last study device removal to end of study; 3 months
Time to Additional Intervention
Time to additional intervention, if Endo-SPONGE treatment is insufficient.
Measured: Day 0 Study Procedure to the last study device removal; up to 3 months
Leak Recurrence
Leak recurrence within 3 months following completion of Endo-SPONGE therapy.
Measured: From last study device removal to end of study; 3 months
Endo-SPONGE Exchanges
Number of Endo-SPONGE exchanges needed to reach clinical success.
Measured: Day 0 Study Procedure to last study device removal; up to 3 months
Length of Hospitalization
Length of Hospitalization.
Measured: Day 0 Study Procedure to end of study; up to 6 months
Mortality Rate
Mortality rate through 3-month follow-up.
Measured: Day 0 Study Procedure to end of study; up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start2 Nov 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeaksStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Pauli, MD, Principal investigator, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035431
- Sponsor's protocol ID
- E7212
- Acronym
- DRAIN Lower
- Status last verified
- Nov 2026
- First submitted
- 10 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07035431
- Acronym / sponsor ID
- DRAIN Lower / E7212
- Conditions
- Anastomotic Leaks, Hartmanns Stump Leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Vacuum Therapy (EVT) Device | Experimental | Device: Endo-SPONGE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endo-SPONGEThe intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage. | Device | Endoscopic Vacuum Therapy (EVT) Device |
Primary outcome
Serious Adverse Events
Time frame: 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
Time frame: 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.
8 secondary outcomes
Technical Success
Time frame: Day 0 Study Procedure to the last study device exchange; up to 3 months
Closure Time
Time frame: Day 0 Study Procedure to the last study device removal; up to 3 months
Rate of Reinterventions
Time frame: From last study device removal to end of study; 3 months
Time to Additional Intervention
Time frame: Day 0 Study Procedure to the last study device removal; up to 3 months
Leak Recurrence
Time frame: From last study device removal to end of study; 3 months
Endo-SPONGE Exchanges
Time frame: Day 0 Study Procedure to last study device removal; up to 3 months
Length of Hospitalization
Time frame: Day 0 Study Procedure to end of study; up to 6 months
Mortality Rate
Time frame: Day 0 Study Procedure to end of study; up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Pauli, MD principal investigator
Penn State Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-SPONGE in people with Anastomotic Leaks and Hartmanns Stump Leakage, run by Boston Scientific Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve Fodem (651-246-3094, Steve.Fodem@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: Day 0 Study Procedure to end of study; up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.