An interventional study of Endo-SPONGE in Anastomotic Leaks and Hartmanns Stump Leakage, sponsored by Boston Scientific Corporation. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
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.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's planned enrollment of 66 is below the median of 140 across 128 interventional studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Endo-SPONGE
The intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
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.
Time frame: 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.
Time frame: Day 0 Study Procedure to the last study device removal; up to 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From last study device removal to end of study; 3 months
Endo-SPONGE Exchanges
Number of Endo-SPONGE exchanges needed to reach clinical success.
Time frame: Day 0 Study Procedure to last study device removal; up to 3 months
Length of Hospitalization
Length of Hospitalization.
Time frame: Day 0 Study Procedure to end of study; up to 6 months
Mortality Rate
Mortality rate through 3-month follow-up.
Time frame: Day 0 Study Procedure to end of study; up to 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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