Clinical Trial: Eso-Sponge Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatr

Brief 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.

Detailed Summary:

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.


Sponsor: Aesculap AG

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Eso-SPONGE® changes [ Time Frame: 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
  • Average replacement intervals [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Period of time between exchange of ESO-Sponge®
  • Duration of endoscopic vacuum therapy [ Time Frame: until day of discharge (approximately 2 weeks) ]
    Number of days during which Eso-SPONGE® was applied
  • 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)


Original Secondary Outcome: Same as current

Information By: Aesculap AG

Dates:
Date Received: January 19, 2016
Date Started: January 2015
Date Completion: January 2020
Last Updated: November 25, 2016
Last Verified: November 2016