Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Endo-SPONGE
DeviceThe intervention involves the placement of an Endo-SPONGE in the leakage cavity, and applying suction to facilitate drainage.
Treatment groups
66 Participants
are divided into 1 treatment groupGroup A: Endoscopic Vacuum Therapy (EVT) DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov