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

NCT03962179 | Unknown DMC

• 1 other identifier: 19-1053_1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Perforation Esophagus; Esophageal Cancer; Esophageal Achalasia; Esophageal Diseases

Keywords

Perforation Esophagus, Esophageal Anastomotic Leak,

Outcome Measures

Primary Outcomes (1)

• Technique - % of patients with successful implantation of VACStent

  % 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 Outcomes (6)

• Healing of leak - % 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

• Treatment of sepsis

  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

  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

  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

  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

Study Arms (1)

VACStent Group

EXPERIMENTAL

Patient s who received a VACStent

Device: VACStent

Interventions

VACStent DEVICE

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

VACStent Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Simultaneous participation in other interventional exams
• Endoscopic inaccessibility of the affected section
• Unstable patients with severe septic disease, who have a clinical history
• Assessment an immediate operation for safe focus switch-off requires
• Persons who are in a dependency / employment relationship with the sponsor or examiner stand
• Accommodation in an institution for judicial or regulatory purposes arrangement

Sponsors & Collaborators

• University Hospital of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (2)

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Esophageal Perforation; Esophageal Neoplasms; Esophageal Achalasia; Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Seung-Hun Chon, M.D.

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: September 22, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)