NCT04884334

Brief Summary

This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

May 4, 2021

Last Update Submit

April 10, 2026

Conditions

Perforation of the ColonPerforation of the Oesophagus

Keywords

Perforation OesophagusOesophageal Anastomotic Leakendoscopic vacuum therapyPerforation Colon

Outcome Measures

Primary Outcomes (1)

  • Successful treatment of the leakage with the VAC-Stent®

    up to 6 months

Secondary Outcomes (2)

  • Rate of morphological healing of the insufficiency

    approximately 4 weeks after end of treatment

  • Number of Participants with complications

    approximately 4 weeks after end of treatment

Study Arms (1)

VAC-Stent® treatment

spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon

Device: VAC-Stent®

Interventions

VAC-Stent®DEVICE

treatment with the VAC-Stent®

VAC-Stent® treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon

You may qualify if:

  • written informed consent
  • treatment with the VAC-Stent®

You may not qualify if:

  • \- accommodation in an institution under court or administrative order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Charité

Berlin, Germany

Location

Sana Klinikum Lichtenberg

Berlin, Germany

Location

St. Josef-Hospital

Bochum, Germany

Location

Johanniter Krankenhaus Bonn

Bonn, Germany

Location

Ameos Klinikum Am Bürgerpark

Bremerhaven, Germany

Location

Allgemeines Krankenhaus Celle

Celle, Germany

Location

Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital

Cologne, 51109, Germany

Location

Städtisches Klinikum Dresden

Dresden, Germany

Location

Uniklinik Düsseldorf

Düsseldorf, Germany

Location

KRH Klinikum Siloah

Hanover, Germany

Location

Nils Stensen Kliniken, Marienhospital Osnabrück

Osnabrück, Germany

Location

Caritas Klinikum Saarbrücken - St. Theresia

Saarbrücken, Germany

Location

Uniklinik Tübingen

Tübingen, Germany

Location

Asklepios Paulinen Klinik Wiesbaden

Wiesbaden, Germany

Location

Related Publications (2)

  • Heiss MM, Lange J, Knievel J, Yohannes A, Hugle U, Dormann AJ, Eisenberger CF. Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study. Langenbecks Arch Surg. 2024 Jul 31;409(1):234. doi: 10.1007/s00423-024-03426-5.

    PMID: 39083099DERIVED

  • Lange J, Knievel J, Wichmann D, Kahler G, Wiedbrauck F, Hellmich T, Kandler M, Bernhardt J, Scholz D, Beyna T, Hausmann J, Wedi E, Ellrichmann M, Hugle U, Dormann AJ, Eisenberger CF, Heiss MM. Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept. Front Surg. 2023 May 5;10:1182094. doi: 10.3389/fsurg.2023.1182094. eCollection 2023.

    PMID: 37215348DERIVED

MeSH Terms

Conditions

Esophageal Perforation

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 13, 2021

Study Start

July 1, 2020

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(14)