Sponge treatment may fix dangerous gut leaks without more surgery
NCT ID NCT07035431
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This study tests a sponge device called Endo-SPONGE to treat leaks that can happen after colorectal surgery. The sponge is placed into the leak cavity and uses suction to drain fluid and help the leak close. Researchers will check if the sponge is safe and effective in 66 adults, aiming to avoid additional surgeries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endo-SPONGE device
- What this could lead to
- If successful, this could offer a less invasive way to close post-surgery leaks, potentially avoiding repeat surgeries and speeding recovery.
- What could go wrong
- This is a small, early-stage trial (66 people) testing a device. It may not work for all leak types, and there are risks of infection or device-related complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Florida
NOT_YET_RECRUITINGWeston, Florida, 33331, United States
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Cleveland Clinic Foundation
NOT_YET_RECRUITINGCleveland, Ohio, 44195, United States
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Lahey Medical Center
NOT_YET_RECRUITINGBurlington, Massachusetts, 01805, United States
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Marshall University Medical Center
RECRUITINGHuntington, West Virginia, 25701, United States
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Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Orlando Regional Medical Center
NOT_YET_RECRUITINGOrlando, Florida, 32806, United States
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Penn State Health
RECRUITINGHershey, Pennsylvania, 17033, United States
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Thomas Jefferson University Hospital
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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University of California, Davis Medical Center
NOT_YET_RECRUITINGSacramento, California, 95817, United States
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University of Washington Medical Center
RECRUITINGSeattle, Washington, 98195, United States
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