A prospective feasibility study on the treatment of gastrointestinal leakage by the use of combination of covered nitinol stent and negative pressure wound treatment

A prospective feasibility study on the treatment of gastrointestinal leakage by the use of combination of covered nitinol stent and negative pressure wound treatment - VAC-Stent

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016048

Enrollment

Registered

2019-01-22

Start date

2019-08-26

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

K22.3 K63.1

Interventions

Group 1: Patients with spontaneous iatrogenic or postoperative leakage in the esophagus (15 patients) or colon (15 patients) are treated with the VAC stent (Möller Medical GmbH), a combination of a ni

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Presence of a written consent of the patient • Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus • Accessibility of the leakage with the delivery system of the VAC stent

Exclusion criteria

Exclusion criteria: • Simultaneous participation in other interventional trials • Endoscopic inaccessibility of the affected section • Full anticoagulation with INR > 1.5 and/or PTT > 50 sec, or platelets < 20.000/µl (after therapeutic correction an inclusion is possible) • Unstable patients with a severe septic condition who require an immediate operation • ileus image with constant vomiting (after gastric tube and gastric emptyingan inclusion is possible) • Persons who are in a dependency / employment relationship with the sponsor or investigator • Accommodation in an institution under court or administrative order

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to evaluate the suitability of the medical device for sealing leaks in the esophagus or colon. The technical application is checked every time the stent is changed, measured by whether the stent can be successfully implanted and seals the leakage.	—

Secondary

Measure	Time frame
• Prevention/elemination of sepsis • Morphological healing of insufficiency • detection of complications (stent dislocation, erosion of tissue structures in the abscess cavity / in the esophagus or colon / bleeding)	—

Countries

Germany

Contacts

Public ContactMarkus M. Heiss

Klinik für Viszeral-, Tumor-, Transplantations- und Gefäßchirurgie, Klinikum Köln-Merheim

HeissM@kliniken-koeln.de0221/8907-3770

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026