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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03962179
Recruitment Status : Active, not recruiting
First Posted : May 23, 2019
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Seung-Hun Chon, University Hospital of Cologne

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Perforation Esophagus Esophageal Cancer Esophageal Achalasia Esophageal Diseases Device: VACStent Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Actual Study Start Date : September 22, 2019
Actual Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03962179


Locations
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Germany
University Hospital of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University Hospital of Cologne
Investigators
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Principal Investigator: Seung-Hun Chon, M.D. University Hospital of Cologne
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seung-Hun Chon, PI, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT03962179    
Other Study ID Numbers: 19-1053_1
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung-Hun Chon, University Hospital of Cologne:
Perforation Esophagus, Esophageal Anastomotic Leak,
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Diseases
Esophageal Perforation
Digestive System Diseases
 Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Wounds and Injuries