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Biodegradable Stents in the Management of Stenoses of the Large Airways

NCT02620319 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-31

No results posted yet for this study

Summary

The objective of this project is to determine whether biodegradable polydioxanone stents are efficient in the treatment of adult patients with tracheobronchial stenoses.

Conditions

  • Tracheal Stenosis

Interventions

DEVICE

SX-ELLA Stent DV Tracheal (DV Stent)

The trachea is intubated with a rigid bronchoscope while participants are placed under total intravenous anesthesia and jet ventilation. The delivery apparatus containing the stent is introduced through a rigid tube to the desired depth under visual control. Then the stent is deployed and its position is determined and, if necessary, stent is repositioned using rigid forceps. In-stent balloon dilation is carried out. If needed, thoracic surgeon can secure the stent in place via external (percutaneous) fixation: one suture is passed through the stent, the tracheal wall, soft tissues, and skin; the suture is then knotted on the skin of the neck. The suture is removed two to three weeks after implantation.

Sponsors & Collaborators

  • Ministry of Health, Czech Republic

    collaborator OTHER_GOV

  • University Hospital Olomouc

    collaborator OTHER

  • University Hospital, Motol

    collaborator OTHER

  • Ludek Stehlik

    lead OTHER

Principal Investigators

  • Ludek Stehlik, MUDr. · Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

  • Miloslav Marel, Prof. MUDr. · Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital

  • Vitezslav Kolek, Prof. MUDr. · Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc

  • Martina Vasakova, Prof. MUDr. · Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Czechia

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 NCT02620319 on ClinicalTrials.gov