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

NCT03962179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-05

No results posted yet for this study

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

Interventions

DEVICE

VACStent

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

Sponsors & Collaborators

  • University Hospital of Cologne

    lead OTHER

Principal Investigators

  • Seung-Hun Chon, M.D. · University Hospital of Cologne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-22
Primary Completion
2020-11-30
Completion
2021-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962179 on ClinicalTrials.gov