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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Evelyne Ho, MPH, MBA
- Numéro de téléphone: 978-483-8856
- E-mail: evelyne.ho@bsci.com
Lieux d'étude
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Texas
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Dallas, Texas, États-Unis, 76246
- Baylor University Medical Center
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Contact:
- Steven G Leeds, MD
- Numéro de téléphone: 972-817-6050
- E-mail: Steven.leeds@bswhealth.org
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Serious Adverse Events
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Technical Success
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 30-days after study procedure
|
Time to additional intervention, if Eso-SPONGETM treatment is insufficient. |
30-days after study procedure
|
|
Leak Recurrence
Délai: 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
Délai: 30-days after study procedure
|
Number of Eso-SPONGETM exchanges needed to reach clinical success. |
30-days after study procedure
|
|
Length of Hospitalization
Délai: 30 days after study procedure
|
Length of Hospitalization during EVT treatment. |
30 days after study procedure
|
|
Mortality Rate
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E7211
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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