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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

Tracking Information
First Submitted Date May 4, 2021
First Posted Date May 13, 2021
Last Update Posted Date December 1, 2023
Actual Study Start Date July 1, 2020
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2021)		 Successful treatment of the leakage with the VAC-Stent® [ Time Frame: up to 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2021)
  • Rate of morphological healing of the insufficiency [ Time Frame: approximately 4 weeks after end of treatment ]
  • Number of Participants with complications [ Time Frame: approximately 4 weeks after end of treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title VAC-Stent Registry
Official Title Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon
Condition
  • Perforation of the Oesophagus
  • Perforation of the Colon
Intervention Device: VAC-Stent®
treatment with the VAC-Stent®
Study Groups/Cohorts VAC-Stent® treatment
spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon
Intervention: Device: VAC-Stent®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 6, 2021)		 200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- accommodation in an institution under court or administrative order
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Markus M Heiss, Prof Dr +4922189073771 HeissM@kliniken-koeln.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04884334
Other Study ID Numbers VAC-Stent Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Markus M. Heiss, University of Witten/Herdecke
Original Responsible Party Same as current
Current Study Sponsor Markus M. Heiss
Original Study Sponsor Same as current
Collaborators
  • VAC Stent GmbH
  • Möller Medical GmbH
  • MicroTech Europe GmbH
  • University of Witten/Herdecke
Investigators Not Provided
PRS Account University of Witten/Herdecke
Verification Date November 2023