Eso-Sponge Registry

March 30, 2023 updated by: Aesculap AG

International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatrogenic or Spontaneous Esophageal Perforation.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Berka, Germany, 99437
        • Recruiting
        • Zentralklinik Bad Berka
        • Contact:
          • Katrin Eberle, Dr.
      • Freiburg, Germany, 70106
        • Recruiting
        • Universitätsklinikum Freiburg
        • Contact:
          • Jens Höppner, Prof. Dr.
      • Greifswald, Germany, 17475
        • Recruiting
        • Universitätsmedizin Greifswald
        • Contact:
          • Susann Glitsch, Dr.
      • Heinsberg, Germany, 52525
        • Recruiting
        • Städtisches Krankenhaus Heinsberg
        • Contact:
          • Carsten Triller, Dr.
      • Köln, Germany, 50678
        • Recruiting
        • Krankenhaus der Augustinerinnen
        • Contact:
          • Tobias Beckurts, Prof. Dr.
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
          • Doerte Wichmann
    • Baden-Württemberg
      • Pforzheim, Baden-Württemberg, Germany, 75179
        • Recruiting
        • Siloah St. Trudpert Klinikum
        • Contact:
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
      • Herford, Hessen, Germany, 32049
      • Lich, Hessen, Germany, 35423
    • Niedersachsen
      • Lüneburg, Niedersachsen, Germany, 21339
      • Wilhelmshaven, Niedersachsen, Germany, 26389
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Recruiting
        • Augusta-Kliniken GmbH
        • Contact:
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
      • Herne, Nordrhein-Westfalen, Germany, 44623
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitätsklinikum Kiel
        • Contact:
        • Principal Investigator:
          • Nils Heits, Dr.
    • Thüringen
      • Gera, Thüringen, Germany, 07548
        • Recruiting
        • Wald-Klinikum Gera
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with anastomotic leakages after esophageal resection or gastrectomy and spontaneous or iatrogenic esophageal perforations.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eso-SPONGE® vacuum treatment
leakage after esophagectomy and gastrectomy, perforation of the esophagus
Device: Eso-SPONGE® vacuum treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing rate of the esophageal anastomosis leakage or esophageal perforation
Time Frame: until day of discharge (approximately 2 weeks)
Reduction of the cavity, endoscopic vacuum therapy no longer necessary
until day of discharge (approximately 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Eso-SPONGE® changes
Time Frame: until day of discharge (approximately 2 weeks)
until day of discharge (approximately 2 weeks)
Total number of sponges used
Time Frame: until day of discharge (approximately 2 weeks)
Total number of Eso-SPONGE® units used until day of discharge
until day of discharge (approximately 2 weeks)
Average replacement intervals
Time Frame: until day of discharge (approximately 2 weeks)
Period of time between exchange of ESO-Sponge®
until day of discharge (approximately 2 weeks)
Duration of endoscopic vacuum therapy
Time Frame: until day of discharge (approximately 2 weeks)
Number of days during which Eso-SPONGE® was applied
until day of discharge (approximately 2 weeks)
Complication Rate
Time Frame: until day of discharge (approximately 2 weeks)
Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis)
until day of discharge (approximately 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

Universitätsklinikum Kiel

Investigators

  • Study Chair: Clemens Schafmayer, Prof. Dr., Universitätsklinikum Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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