Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent) (VACStent)

July 29, 2021 updated by: Seung-Hun Chon, University Hospital of Cologne

VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VACStent Group
Patient s who received a VACStent
Device: VACStent
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technique - % of patients with successful implantation of VACStent
Time Frame: 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
% of patients with successful implantation of VACStent
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of leak - % of patients with successful implantation of VACStent
Time Frame: 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
% of patients with a sealed leak after successful treatment with VACStent
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
Treatment of sepsis
Time Frame: 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
% of patients with successful treatment of sepsis leak after successful implantation of VACStent
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
Migration rate
Time Frame: 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
% of patients with migration of VACStent after successful implantation of VACStent
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
Bleeding
Time Frame: 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
% of patients with bleeding after successful implantation of VACStent
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
Arrosion of tissue structures
Time Frame: 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
% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent
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
Sealing of leak - % of patients with successful implantation of VACStent
Time Frame: 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
% of patients with a sealed leak after successful treatment with VACStent
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Cologne

Investigators

  • Principal Investigator: Seung-Hun Chon, M.D., University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1053_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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