Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery (DRAIN Upper)
A Prospective Multicenter Trial Evaluating the Safety and Effectiveness of Eso-SPONGE for the Treatment of Anastomotic Leaks in the Upper Gastrointestinal Tract
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study is a prospective multi-center, single -arm study with treatment of up to 74 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the Eso-Sponge and up to 4 months follow-up.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Evelyne Ho, MPH, MBA
- Telefoonnummer: 978-483-8856
- E-mail: evelyne.ho@bsci.com
Studie Locaties
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Texas
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Dallas, Texas, Verenigde Staten, 76246
- Baylor University Medical Center
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Contact:
- Steven G Leeds, MD
- Telefoonnummer: 972-817-6050
- E-mail: Steven.leeds@bswhealth.org
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria
-
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
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Subject has an anastomotic leak in the esophagus or stomach that is endoscopically accessible within the range of the overtube length.
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Subject is eligible for endoscopic intervention.
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Subject has a transmural defect of at least 2 cm in diameter in the esophagus or stomach.
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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.
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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 leak.
- Subject had upper gastrointestinal surgery resulting in the leak more than 60 days prior to the planned study procedure.
- Subject has any necrotic tissue that would require endoscopic debridement prior to Eso-SPONGETM placement.
- Subject has known contraindication for EVT as per the Investigator Brochure (IB)
- Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Eso-Sponge(TM)
Patients who meet all the inclusion criteria and none of the exclusion criteria will have an Eso-Sponge(TM) placed for the treatment of anastomotic leaks in the upper gastrointestinal tract. |
Treatment 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Serious Adverse Events
Tijdsspanne: Within 3-4 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. |
Within 3-4 months
|
|
Clinical Success
Tijdsspanne: 30-Days after study procedure
|
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. |
30-Days after study procedure
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Technical Success
Tijdsspanne: 30-Days after study procedure
|
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. |
30-Days after study procedure
|
|
Closure Time
Tijdsspanne: 30-days after study procedure
|
Time to anastomotic leak closure from the surgery that led to the leak. |
30-days after study procedure
|
|
Closure Time
Tijdsspanne: Through end of study, up to 4 months
|
Time to leak closure from the initial study procedure. |
Through end of study, up to 4 months
|
|
Rate of Reinterventions
Tijdsspanne: Through study completion, an average of 3 to 4 months
|
Rate of Reinterventions after closure of the anastomotic leak. |
Through study completion, an average of 3 to 4 months
|
|
Time to Additional Intervention
Tijdsspanne: 30-days after study procedure
|
Time to additional intervention, if Eso-SPONGETM treatment is insufficient. |
30-days after study procedure
|
|
Leak Recurrence
Tijdsspanne: Through study completion, an average of 3 to 4 months
|
Anastomotic leak recurrence within 3-months following completion of Eso-SPONGETM therapy. |
Through study completion, an average of 3 to 4 months
|
|
Eso-SPONGE Exchanges
Tijdsspanne: 30-days after study procedure
|
Number of Eso-SPONGETM exchanges needed to reach clinical success. |
30-days after study procedure
|
|
Length of Hospitalization
Tijdsspanne: 30 days after study procedure
|
Length of Hospitalization during EVT treatment. |
30 days after study procedure
|
|
Mortality Rate
Tijdsspanne: Through study completion, an average of 3 to 4 months
|
Mortality rate through 3-month follow-up. |
Through study completion, an average of 3 to 4 months
|
|
Unplanned Hospital Re-admissions
Tijdsspanne: Through study completion, an average of 3 to 4 months
|
Unplanned hospital re-admission related to the leak within 90 days of initial discharge. |
Through study completion, an average of 3 to 4 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E7211
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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