Eso-Sponge Registry

  • STATUS
    Recruiting
  • End date
    Jan 15, 2023
  • participants needed
    200
  • sponsor
    Aesculap AG
Updated on 26 January 2022

Summary

This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.

Description

Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician.

Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE.

Eso-SPONGE represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients.

The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.

Details
Condition Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus
Treatment Eso-SPONGE® vacuum treatment
Clinical Study IdentifierNCT02662777
SponsorAesculap AG
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
age > 18 years
written informed consent

Exclusion Criteria

none
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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