## Protocol Section
### Identification Module
**NCT ID:** NCT03962179

**Acronym:** VACStent

**Brief Title:** Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (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

#### Organization Study ID Info
**ID:** 19-1053_1
#### Organization
**Class:** OTHER
**Full Name:** University Hospital of Cologne
### Status Module
#### Completion Date
**Date:** 2021-11-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2021-08-05

**Type:** ACTUAL

**Last Update Submit Date:** 2021-07-29

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-09-22

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2019-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-21
**Study First Submit QC Date:** 2019-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital of Cologne

#### Responsible Party

**Investigator Affiliation:** University Hospital of Cologne

**Investigator Full Name:** Seung-Hun Chon

**Investigator Title:** PI

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Perforation Esophagus

- Esophageal Cancer

- Esophageal Achalasia

- Esophageal Diseases

**Keywords:**

- Perforation Esophagus, Esophageal Anastomotic Leak,

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient s who received a VACStent

**Intervention Names:**

- Device: VACStent

**Label:** VACStent Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VACStent Group

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

**Name:** VACStent

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** % of patients with successful implantation of VACStent

**Measure:** 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

#### Secondary Outcomes

**Description:** % of patients with a sealed leak after successful treatment with VACStent

**Measure:** 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

**Description:** % of patients with successful treatment of sepsis leak after successful implantation of VACStent

**Measure:** 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

**Description:** % of patients with migration of VACStent after successful implantation of VACStent

**Measure:** 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

**Description:** % of patients with bleeding after successful implantation of VACStent

**Measure:** 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

**Description:** % of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent

**Measure:** 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

**Description:** % of patients with a sealed leak after successful treatment with VACStent

**Measure:** 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

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cologne

**Country:** Germany

**Facility:** University Hospital of Cologne

**State:** NRW

**Zip:** 50937

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital of Cologne

**Name:** Seung-Hun Chon, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 31791095

**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.

**PMID:** 34561712

#### See Also Links

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

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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8081

- Name: Esophageal Achalasia

- Relevance: HIGH

- As Found: Esophageal Achalasia

- ID: M8085

- Name: Esophageal Diseases

- Relevance: HIGH

- As Found: Esophageal Diseases

- ID: M28891

- Name: Anastomotic Leak

- Relevance: LOW

- As Found: Unknown

- ID: M8089

- Name: Esophageal Perforation

- Relevance: HIGH

- As Found: Perforation Esophagus

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

- ID: T2993

- Name: Idiopathic Achalasia

- Relevance: HIGH

- As Found: Esophageal Achalasia

- ID: T970

- Name: Cardiospasm

- Relevance: HIGH

- As Found: Esophageal Achalasia

### Condition Browse Module - Meshes

- ID: D000004931

- Term: Esophageal Achalasia

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000004939

- Term: Esophageal Perforation

### Misc Info Module

- Version Holder: 2024-05-24
