This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

VAC-Stent Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04884334
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : December 1, 2023
Sponsor:
Collaborators:
VAC Stent GmbH
Möller Medical GmbH
MicroTech Europe GmbH
University of Witten/Herdecke
Information provided by (Responsible Party):
Markus M. Heiss, University of Witten/Herdecke

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Perforation of the Oesophagus Perforation of the Colon Device: VAC-Stent®

Detailed Description:

For this registry, quality assurance data will be prospectively collected from all patients who receive the VAC-Stent®. The VAC-Stent® combines a vacuum sponge, which lies intraluminal and conditions the wound, with a covered stent, which seals the sponge from the lumen and thus ensures passage. Due to its design, the new medical device VAC-Stent® offers a solution for the most important problems of the covered stent, the stent migration and the lack of drainage function, as well as for those of the endoluminal vacuum sponge, the blockage of the gastrointestinal lumen and the difficult application. The VAC-Stent® is the technical advancement for all indications of the covered stent and for the indication of the endoluminal vacuum sponge, so that a very good effectiveness with reduced complications can be expected for these clinical situations.

The VAC-Stent® therefore offers the prospect of an innovative further development in the endoscopic treatment of leaks in the gastrointestinal tract, without any new and unknown risks being associated with it.

The primary aim of this registry is to collect data on the quality assurance and application of the VAC-Stent® and thus to evaluate the suitability of the VAC-Stent® for sealing leaks in the oesophagus or colon. In addition, the safety and efficacy of the VAC-Stent® will be demonstrated.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
VAC-Stent® treatment
spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon
 Device: VAC-Stent®
treatment with the VAC-Stent®


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Successful treatment of the leakage with the VAC-Stent® [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Rate of morphological healing of the insufficiency [ Time Frame: approximately 4 weeks after end of treatment ]
  2. Number of Participants with complications [ Time Frame: approximately 4 weeks after end of treatment ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- accommodation in an institution under court or administrative order

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884334


Contacts
Layout table for location contacts
Contact: Markus M Heiss, Prof Dr +4922189073771 HeissM@kliniken-koeln.de

Locations
Layout table for location information
Germany
Johanniter Krankenhaus Bonn Recruiting
Bonn, Germany
Ameos Klinikum Am Bürgerpark Recruiting
Bremerhaven, Germany
Allgemeines Krankenhaus Celle Recruiting
Celle, Germany
Städtisches Klinikum Dresden Recruiting
Dresden, Germany
Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital Recruiting
Köln, Germany, 51109
Contact: Markus M Heiss, Prof Dr    +4922189073771    HeissM@kliniken-koeln.de   
Uniklinik Tübingen Recruiting
Tübingen, Germany
Asklepios Paulinen Klinik Wiesbaden Recruiting
Wiesbaden, Germany
Sponsors and Collaborators
Markus M. Heiss
VAC Stent GmbH
Möller Medical GmbH
MicroTech Europe GmbH
University of Witten/Herdecke
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Markus M. Heiss, Prof Dr, University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT04884334    
Other Study ID Numbers: VAC-Stent Registry
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Markus M. Heiss, University of Witten/Herdecke:
Perforation Oesophagus
Oesophageal Anastomotic Leak
endoscopic vacuum therapy
Perforation Colon