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Biodegradable Stents in the Management of Stenoses of the Large Airways

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ClinicalTrials.gov Identifier: NCT02620319
Recruitment Status : Unknown
Verified December 2015 by Ludek Stehlik, Thomayerova Teaching Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2015
Last Update Posted : June 17, 2016
Sponsor:
Collaborators:
Ministry of Health, Czech Republic
University Hospital Olomouc
University Hospital, Motol
Information provided by (Responsible Party):
Ludek Stehlik, Thomayerova Teaching Hospital

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

Condition or disease Intervention/treatment Phase
Tracheal Stenosis Device: SX-ELLA Stent DV Tracheal (DV Stent) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biodegradable Stents in the Management of Stenoses of the Large Airways
Study Start Date : May 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: biodegradable stent
endoscopic implantation of biodegradable airway stent, the SX-ELLA Stent DV Tracheal (DV Stent)
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.
Other Name: DV Stent




Primary Outcome Measures :
  1. airway patency during the presence of the stent in the airways [ Time Frame: residence time of the stent in the airways, i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support ]
    Scheduled bronchoscopies, trachea is, for the purposes of the study, classified according to Freitag's recommended adapted classification system (Freitag L. et al. A proposed classification system of central airway stenosis, Eur Respir J 2007; 30:7-12).


Secondary Outcome Measures :
  1. number of complications: infection, bleeding, migration, obstructive granulation tissue formation, sudden restenosis (of any origin, unexpected in relation to the degree of the stent degradation) [ Time Frame: residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter ]
  2. evaluation of forced expiratory volume in 1 second (FEV1) [ Time Frame: residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter ]
    FEV1 (in liters and % predicted values) measurements within follow-ups.

  3. evaluation of forced vital capacity (FVC) [ Time Frame: residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter ]
    FVC (in liters and % predicted values) measurements within follow-ups.

  4. airway patency after complete degradation of the stent or loss of majority support functions [ Time Frame: six months, beginning after identifying the complete degradation of the stent or 180 days after implantation ]
    Scheduled bronchoscopies, trachea is, for the purposes of the study, classified according to Freitag's recommended adapted classification system (Freitag L. et al. A proposed classification system of central airway stenosis, Eur Respir J 2007; 30:7-12).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • significant large airway stenoses
  • benign tracheobronchial stenosis of any origin in participants who can not go for surgery, or who refuse surgical treatment
  • benign tracheobronchial stenoses of any origin when the surgery is planed after some delay, benign tracheobronchial stenoses when the effect of anti- inflammatory or anti-infective treatment is expected
  • malignant tracheobronchial stenoses due to extrinsic compression when exhausted curative modalities
  • malignant stenoses from extrinsic compression in participants undergoing the actinotherapy or receiving systemic anticancer therapy

Exclusion Criteria:

  • stenoses of any origin which can be treated primarily surgically
  • stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620319


Locations
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Czech Republic
Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc
Olomouc, Czech Republic, 779 00
Department of Respiratory Medicine, Thomayer Hospital
Prague, Czech Republic, 140 59
Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital
Prague, Czech Republic, 150 06
Sponsors and Collaborators
Ludek Stehlik
Ministry of Health, Czech Republic
University Hospital Olomouc
University Hospital, Motol
Investigators
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Principal Investigator: Ludek Stehlik, MUDr. Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4
Study Director: Miloslav Marel, Prof. MUDr. Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital
Study Director: Vitezslav Kolek, Prof. MUDr. Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc
Study Director: Martina Vasakova, Prof. MUDr. Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

Publications of Results:
Other Publications:

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Responsible Party: Ludek Stehlik, MUDr., Thomayerova Teaching Hospital
ClinicalTrials.gov Identifier: NCT02620319     History of Changes
Other Study ID Numbers: NT 14146-3/2013
NT14146 ( Other Grant/Funding Number: Internal Grant Agency of the Czech Ministry of Health )
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: December 2015
Keywords provided by Ludek Stehlik, Thomayerova Teaching Hospital:
bronchoscopy
polydioxanone
absorbable implants
stents
Additional relevant MeSH terms:
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Tracheal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Tracheal Diseases
Respiratory Tract Diseases