Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

Background: The ideal airway stent has yet to be developed. Biodegradable (BD) stents are made of knitted polymer fibers that degrade when placed in the body; extraction of the device is, therefore, unnecessary. Several in vitro and in vivo studies of tracheal BD stents composed of various materials have been conducted. Polydioxanone is a biodegradable polymer in the polyester family, which has attracted a lot of interest due to its exquisite biocompatibility and is currently available on the market in the form of absorbable suture material. It is degraded by hydrolysis (of its ester bonds), which is accelerated under low potential of Hydrogen (pH) conditions, into harmless degradation products. Polydioxanone tracheal stents appear to be well tolerated by the tracheal mucosa, retain their mechanical strength for as long as 6 weeks, and, in animal models, completely degrade after approximately 15 weeks. They have been successfully used in humans as mechanical support for tracheal transplants, during treatment of obstructive airway complications after lung transplantation, and in children with airway stenosis. Hypotheses: Biodegradable stents can be used in adult patients as a temporary mechanical support of narrowed airways, they allow healing of the airways or secure the airways until another (anticancer, anti-inflammatory) therapy manages the cause of the narrowing. Biodegradable stents are expected to have advantages over classical stents, namely good biocompatibility, fair adaptation to the anatomy of the airways, they do not limit the transportation of secretions substantially. Objectives: The primary objective of this study is to show that BD stents can be safely used and are effective in the treatment of adult patients with tracheal narrowings. The secondary objectives are: to observe and analyze mucosa - BD stent interaction, to assess degradation of stents and its consequences. Design: Prospective interventional study conducted in three hospitals in the Czech Republic. Methods: The investigators intend to enroll adult participants suffering from significant large airway stenoses in which the stenting is generally considered to be effective. Every participant is reviewed by at least two interventional pulmonologists and a thoracic surgeon to determine the best therapeutic option. Bronchoscopy and computed tomography of the trachea is considered essential to confirm the diagnoses. All participants sign an informed consent form prior to undergoing the procedure. During the stent implantation, the trachea is intubated with a rigid bronchoscope, participants are placed under total intravenous anesthesia and jet ventilation. The investigators intend to use self-expandable, biodegradable, polydioxanone tracheal stents, the SX-ELLA Stent DV Tracheal (DV Stent), manufactured by ELLA-CS, s.r.o., Hradec Kralove, Czech Republic. Stent is standardly equipped with radiopaque markers at distal and proximal end. It is delivered in sterile packed, separately from original delivery system into which the stent immediately before implantation is placed. As mentioned, stent is made of synthetic polymer - braided polydioxanone fiber widely used for absorbable surgical suture. The suture has successfully been used in the surgery, orthopedics and dental surgery for more than 25 years. It is known that the material is subjected to the bulk hydrolytic degradation in the body. No toxic substances arise within the degradation process. The ultimate degradation substance is 2-hydroxyacetic acid that is finally metabolized to water and carbon dioxide. The data about local reaction produced by polydioxanone implants, incl. buried sutures are contradictory. Majority of them report very low tissue reaction. The first bronchoscopy follow up is carried out during the first post-implantation week, additional follow-ups (including clinical evaluation, bronchoscopy, basic spirometry, and chest X-ray if needed) are performed on a monthly or as-needed basis. If the restenosis threatens, the participant can be given another polydioxanone stent, as well as, he or she can be treated using mechanical removal of obstacles, balloon dilation, laser therapy and electrocautery. Results are analyzed continuously, final evaluation is intended to be performed after reaching a sufficient number of participants. This includes statistical analysis of overall results in participants after complete stent degradation, assessment of major clinical signs and functional parameters, and especially, evaluations of endoscopic findings. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02620319
Study type Interventional
Source Thomayer University Hospital
Contact
Status Suspended
Phase N/A
Start date May 2013
Completion date December 2024

See also
  Status Clinical Trial Phase
Suspended NCT02949414 - A Study to Assess the Safety, Tolerability and Potential Efficacy of a Tracheal Replacement Consisting of a Tissue-engineered Tracheal Scaffold With Seeded Mesenchymal Cells Phase 1
Not yet recruiting NCT03411928 - Endotracheal Dilator to Improve Oxygenation N/A
Recruiting NCT05028023 - Tracheal Dilatation in Pediatric Patients With Acquired Tracheal Stenosis, and the Effects of Apneic Oxygenation N/A
Completed NCT02796326 - Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures N/A
Completed NCT06121024 - Long-term Outcomes of Post-intubation Tracheal Stenosis; 7-year Follow-up
Recruiting NCT02961387 - A Clinical Trial on Effectiveness and Safety of Hydrogen Generator to Treat Dyspnea for the Patients With Tracheal Stenosis: A Randomized, Double-blind and Single-center Clinical Study N/A
Completed NCT02855502 - Investigation of the Effect of Systemic Steroids on Treatment and Prevention of Recurrent Tracheal Stenosis in Postoperative Patients Phase 4
Completed NCT04674995 - Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
Completed NCT01331863 - Airway and/or Pulmonary Vessels Transplantation Phase 1/Phase 2
Not yet recruiting NCT05835713 - Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam N/A
Recruiting NCT03455881 - Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
Recruiting NCT04719845 - DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis N/A
Completed NCT05317923 - Airway Management During Unusual Tracheal Stenosis N/A
Enrolling by invitation NCT05535803 - Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells Phase 2
Completed NCT00705848 - Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis N/A
Completed NCT03130374 - Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells Phase 1/Phase 2
Completed NCT06061380 - Challenges and Management of Post-intubation Tracheal Stenosis
Not yet recruiting NCT04625400 - Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis N/A
Enrolling by invitation NCT04850742 - Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices N/A
Completed NCT05682651 - Relationship Between Post-Intubation Tracheal Stenosis and Covid-19