Actively Recruiting
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Led by Aesculap AG · Updated on 2025-11-17
44
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
A
Aesculap AG
Lead Sponsor
B
B.Braun Surgical SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer. The main objective is to evaluate the potential protective effect of prophylactic preemptive endoluminal vacuum therapy on esophageal-gastric anastomosis dehiscence after esophagectomy.
CONDITIONS
Official Title
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for total minimally invasive transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer with planned Eso-SPONGE application to prevent anastomotic leakage
- Able to read and understand the Patient Information Sheet and sign the Informed Consent Form
- Able to comply with study requirements and attend all assessments as judged by the investigator
You will not qualify if you...
- Undergoing transhiatal esophagectomy without reconstruction, open Ivor Lewis esophagectomy, or other esophageal resections different from ttMILE
- Multi-organ resection during esophagectomy
- Emergency or urgent esophagectomy
- Coloplasty or small bowel plasty
- Presence of necrotic tissue or gangrene
- Blood clotting disorders
- Bleeding esophageal varices
- Sponge placement required directly on major blood vessels
- Known allergies or sensitivities to study device components
- Participation in another clinical trial or use of experimental drugs/devices within 4 weeks prior to study inclusion
- Women who are pregnant, suspected pregnant, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
Research Team
J
Jaume Garcia López, Dr.
CONTACT
J
José Manuel M Molina, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here