Clinical trial · Interventional
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
NCT03962179CI-TRIAL-00053111VACStentunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication. Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Achalasia | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Diseases | — | UNRESOLVED | — |
| Perforation Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VACStent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VACStent Group
- description
- Patient s who received a VACStent
- interventionNames
- Device: VACStent
Primary outcomes (1)
- measure
- Technique - % of patients with successful implantation of VACStent
- timeFrame
- From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
- description
- % of patients with successful implantation of VACStent
Secondary outcomes (6)
- measure
- Healing of leak - % of patients with successful implantation of VACStent
- timeFrame
- From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination * Accessibility of the leak with the delivery system of the VAC stent Exclusion Criteria: * Simultaneous participation in other interventional exams * Endoscopic inaccessibility of the affected section * Full anticoagulation with international normalized ratio (INR) \> 1.5 and / or partial thromboplastin time (PTT) \> 50 sec, or platelets \<20.000 / μl (after therapeutic correction an inclusion is possible) * Unstable patients with severe septic disease, who have a clinical history * Assessment an immediate operation for safe focus switch-off requires * Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible) * Persons who are in a dependency / employment relationship with the sponsor or examiner stand * Accommodation in an institution for judicial or regulatory purposes arrangement
References
Publications (2)
- BACKGROUNDChon SH, Bartella I, Burger M, Rieck I, Goeser T, Schroder W, Bruns CJ. VACStent: a new option for endoscopic vacuum therapy in patients with esophageal anastomotic leaks after upper gastrointestinal surgery. Endoscopy. 2020 May;52(5):E166-E167. doi: 10.1055/a-1047-0244. Epub 2019 Dec 2. No abstract available. PMID 31791095
- DERIVEDChon SH, Scherdel J, Rieck I, Lorenz F, Dratsch T, Kleinert R, Gebauer F, Fuchs HF, Goeser T, Bruns CJ. A new hybrid stent using endoscopic vacuum therapy in treating esophageal leaks: a prospective single-center experience of its safety and feasibility with mid-term follow-up. Dis Esophagus. 2022 Apr 19;35(4):doab067. doi: 10.1093/dote/doab067. PMID 34561712