Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
ConditionAnastomotic Leaks
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed Type II anastomotic leaks in the esophagus or stomach
Type I: Leak requiring no change in treatment
Type II: Leak requiring intervention but not surgery
Type III: Leak requiring surgical intervention
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 leak.
Subject had upper gastrointestinal surgery resulting in the leak more than 60 days prior to the planned study procedure.
Trial design
Design model
Single group
Treatments tested in this trial
sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
DeviceTreatment of anastomotic leaks or perforations in the upper gastrointestinal tract by means of negative pressure including intraluminal or intracavitary therapy of paraoesophageal and mediastinal septic focus or localized abscesses that are endoscopically accessible within the range of the overtube length.
Treatment groups
74 Participants
are divided into 1 treatment groupGroup A: Eso-Sponge(TM)Experimental 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
Within 3-4 months2
Clinical Success
The proportion of subjects that demonstrate clinical success, which is defined as closure of the anastomotic leak or perforation in the upper GIT, confirmed via endoscopy or contrast-enhanced computed tomography imaging within 30 days after the study procedure without the need for an additional intervention. Note: Subjects without clinical success will be followed until the leak resolves or a permanent disease process stabilizes, up to 3 months post final sponge removal.
Time frame
30-Days after study procedureOther outcomes
1
Technical Success
Defined as the ability to deploy the Eso-SPONGE in the intended position. This will be calculated for each study procedure and Eso-SPONGE Exchange.
Time frame
30-Days after study procedure2
Closure Time
Time to anastomotic leak closure from the surgery that led to the leak.
Time frame
30-days after study procedure3
Closure Time
Time to leak closure from the initial study procedure.
Time frame
Through end of study, up to 4 months4
Rate of Reinterventions
Rate of Reinterventions after closure of the anastomotic leak.
Time frame
Through study completion, an average of 3 to 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: