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Eso-Sponge Registry

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02662777
Enrollment
108
Registered
2016-01-26
Start date
2015-01-31
Completion date
2023-12-31
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus

Keywords

esophageal anastomosis leakage, endoscopic vacuum therapy, esophageal perforation, upper gastrointestinal tract, esophageal leak, endoscopy

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 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.

Interventions

DEVICEEso-SPONGE® vacuum treatment

Sponsors

Universitätsklinikum Kiel
CollaboratorUNKNOWN
Aesculap AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Healing rate of the esophageal anastomosis leakage or esophageal perforationuntil day of discharge (approximately 2 weeks)Reduction of the cavity, endoscopic vacuum therapy no longer necessary

Secondary

MeasureTime frameDescription
Number of Eso-SPONGE® changesuntil day of discharge (approximately 2 weeks)
Total number of sponges useduntil day of discharge (approximately 2 weeks)Total number of Eso-SPONGE® units used until day of discharge
Average replacement intervalsuntil day of discharge (approximately 2 weeks)Period of time between exchange of ESO-Sponge®
Duration of endoscopic vacuum therapyuntil day of discharge (approximately 2 weeks)Number of days during which Eso-SPONGE® was applied
Complication Rateuntil day of discharge (approximately 2 weeks)Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026