RecruitingNCT06097078

Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer

Prospective, Multi-centre, Exploratory and Observational One-arm Study to Evaluate Preemptive Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer


Sponsor

Aesculap AG

Enrollment

44 participants

Start Date

Oct 7, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special foam-based drain (called eso-SPONGE or endoluminal vacuum therapy) placed inside the throat after surgery for esophageal cancer. The goal is to prevent a serious complication called anastomotic leakage — where the surgically connected tissue doesn't seal properly — which can be life-threatening. **You may be eligible if...** - You are 18 years or older - You are scheduled for a specific minimally invasive esophageal cancer surgery (called laparoscopic or robotic Ivor Lewis esophagectomy) - You are able to understand and sign a consent form - You are willing and able to follow the study's requirements **You may NOT be eligible if...** - You need open (non-minimally invasive) esophageal surgery - You need emergency esophageal surgery - You have blood clotting problems - You are pregnant, breastfeeding, or may be pregnant - You have bleeding in your esophagus due to varicose-like veins - You are allergic to any components of the device - You are currently participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEso-SPONGE®

minimally invasive treatment and prevention of anastomotic leakages and perforations in the upper gastrointestinal tract (upper GIT)


Locations(1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

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NCT06097078


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