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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Scheduled for total minimally invasive (laparoscopic or robotic and thoracoscopic) transthoracic Ivor Lewis esophagectomy (ttMILE) due to esophageal cancer and subsequent eso-SPONGE application to prevent anastomotic leakage

• Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form

• Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.

Locations
Other Locations
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Jaume Garcia López, Dr.
info@bbraun.com
+34935866200
Backup
José Manuel M Molina, Dr.
info@bbraun.com
+34 935 86 62
Time Frame
Start Date: 2024-10-07
Estimated Completion Date: 2026-04
Participants
Target number of participants: 44
Treatments
Eso-SPONGE®
endoluminal vacuum therapy to prevent anastomotic leakage after esophagectomy due to esophageal cancer
Related Therapeutic Areas
Sponsors
Collaborators: B.Braun Surgical SA
Leads: Aesculap AG

This content was sourced from clinicaltrials.gov