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Completed

NCT Number: NCT02662777

Eso-Sponge Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Siloah St. Trudpert Klinikum, Pforzheim, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eso-SPONGE® vacuum treatment

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Eso-SPONGE® changes

    Time frame: until day of discharge (approximately 2 weeks)

  2. 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

  3. Average replacement intervals

    Time frame: until day of discharge (approximately 2 weeks)

    Period of time between exchange of ESO-Sponge®

  4. Duration of endoscopic vacuum therapy

    Time frame: until day of discharge (approximately 2 weeks)

    Number of days during which Eso-SPONGE® was applied

  5. 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)

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • University of Kiel

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2016
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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