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

Primary Purpose

Perforation Esophagus, Esophageal Cancer, Esophageal Achalasia

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

VACStent

About this trial

This is an interventional treatment trial for Perforation Esophagus focused on measuring Perforation Esophagus, Esophageal Anastomotic Leak,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Cologne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VACStent Group

Arm Description

Patient s who received a VACStent

Outcomes

Primary Outcome Measures

Technique - % of patients with successful implantation of VACStent

% of patients with successful implantation of VACStent

Secondary Outcome Measures

Healing of leak - % of patients with successful implantation of VACStent

% of patients with a sealed leak after successful treatment with VACStent

Treatment of sepsis

% of patients with successful treatment of sepsis leak after successful implantation of VACStent

Migration rate

% of patients with migration of VACStent after successful implantation of VACStent

Bleeding

% of patients with bleeding after successful implantation of VACStent

Arrosion of tissue structures

% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent

Sealing of leak - % of patients with successful implantation of VACStent

% of patients with a sealed leak after successful treatment with VACStent

Full Information

NCT ID

NCT03962179

First Posted

May 21, 2019

Last Updated

July 29, 2021

Sponsor

University Hospital of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT03962179

Brief Title

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

Acronym

VACStent

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 22, 2019 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perforation Esophagus, Esophageal Cancer, Esophageal Achalasia, Esophageal Diseases

Keywords

Perforation Esophagus, Esophageal Anastomotic Leak,

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VACStent Group

Arm Type

Experimental

Arm Description

Patient s who received a VACStent

Intervention Type

Device

Intervention Name(s)

VACStent

Intervention Description

Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract

Primary Outcome Measure Information:

Title

Technique - % of patients with successful implantation of VACStent

Description

% 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

Secondary Outcome Measure Information:

Title

Healing of leak - % of patients with successful implantation of VACStent

Description

% of patients with a sealed leak after successful treatment with 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

Title

Treatment of sepsis

Description

% of patients with successful treatment of sepsis leak after 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

Title

Migration rate

Description

% of patients with migration of VACStent after 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

Title

Bleeding

Description

% of patients with bleeding after 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

Title

Arrosion of tissue structures

Description

% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with 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

Title

Sealing of leak - % of patients with successful implantation of VACStent

Description

% of patients with a sealed leak after successful treatment with 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung-Hun Chon, M.D.

Organizational Affiliation

University Hospital of Cologne

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Cologne

City

Cologne

State/Province

NRW

ZIP/Postal Code

50937

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31791095

Citation

Chon SH, Bartella I, Burger M, Rieck I, Goeser T, Schroder W, Bruns CJ. VACStent: a new option for endoscopic vacuum therapy in patients with esophageal anastomotic leaks after upper gastrointestinal surgery. Endoscopy. 2020 May;52(5):E166-E167. doi: 10.1055/a-1047-0244. Epub 2019 Dec 2. No abstract available.

Results Reference

background

PubMed Identifier

34561712

Citation

Chon SH, Scherdel J, Rieck I, Lorenz F, Dratsch T, Kleinert R, Gebauer F, Fuchs HF, Goeser T, Bruns CJ. A new hybrid stent using endoscopic vacuum therapy in treating esophageal leaks: a prospective single-center experience of its safety and feasibility with mid-term follow-up. Dis Esophagus. 2022 Apr 19;35(4):doab067. doi: 10.1093/dote/doab067.

Results Reference

derived

Links:

URL

https://www.karger.com/Article/Abstract/512320

Description

A Novel Hybrid Stent with Endoscopic Vacuum Therapy for Treating Leaks of the Upper Gastrointestinal Tract

Learn more about this trial

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

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