Tracheal StenosisNCT02620319
Biodegradable Stents in the Management of Stenoses of the Large Airways
A study testing SX-ELLA Stent DV Tracheal (DV Stent) in people with Tracheal Stenosis, run by Ludek Stehlik at 3 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- SX-ELLA Stent DV Tracheal (DV Stent)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesCzechia
- Study dates
- May 2013to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- stenoses of any origin which can be treated primarily surgically
- stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
- pregnancy
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc
Olomouc, 779 00
Department of Respiratory Medicine, Thomayer Hospital
Prague, 140 59
Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital
Prague, 150 06
About this study
The objective of this project is to determine whether biodegradable polydioxanone stents are efficient in the treatment of adult patients with tracheobronchial stenoses.
Read the detailed 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.
- Conditions
- Tracheal Stenosis
- Being tested
- SX-ELLA Stent DV Tracheal (DV Stent)
- Keywords
- bronchoscopy, polydioxanone, absorbable implants, stents
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SX-ELLA Stent DV Tracheal (DV Stent)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| biodegradable stent | Experimental | endoscopic implantation of biodegradable airway stent, the SX-ELLA Stent DV Tracheal (DV Stent) Receives: Device: SX-ELLA Stent DV Tracheal (DV Stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway patency during the presence of the stent in the airways
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).
Measured: 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
Secondary outcomes (4)
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)
Measured: 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
evaluation of forced expiratory volume in 1 second (FEV1)
FEV1 (in liters and % predicted values) measurements within follow-ups.
Measured: 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
evaluation of forced vital capacity (FVC)
FVC (in liters and % predicted values) measurements within follow-ups.
Measured: 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
airway patency after complete degradation of the stent or loss of majority support functions
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).
Measured: six months, beginning after identifying the complete degradation of the stent or 180 days after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startMay 2013
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: The protocol turned out to be not quite suitable for most patients. Apart from Thomayer's hospital, 2 other centers could not cooperate. The introduction of stents continued at the Thomayer Hospital. Publication of results is planned in 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludek Stehlik
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, University Hospital Olomouc, University Hospital, Motol
- Responsible party
- Sponsor-investigator, Ludek Stehlik, Thomayer University Hospital
- Investigators
- Ludek Stehlik, MUDr., Principal investigator, Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4Miloslav Marel, Prof. MUDr., Study director, Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University HospitalVitezslav Kolek, Prof. MUDr., Study director, Department of Respiratory Diseases and Tuberculosis, University Hospital OlomoucMartina Vasakova, Prof. MUDr., Study director, Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620319
- Sponsor's protocol ID
- NT 14146-3/2013
- Other IDs
- NT14146
- Status last verified
- May 2024
- First submitted
- 25 Nov 2015
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Novotny L, Crha M, Rauser P, Hep A, Misik J, Necas A, Vondrys D. Novel biodegradable polydioxanone stents in a rabbit airway model. J Thorac Cardiovasc Surg. 2012 Feb;143(2):437-44. doi: 10.1016/j.jtcvs.2011.08.002. Epub 2011 Aug 31.
PubMed 21885070Lischke R, Pozniak J, Vondrys D, Elliott MJ. Novel biodegradable stents in the treatment of bronchial stenosis after lung transplantation. Eur J Cardiothorac Surg. 2011 Sep;40(3):619-24. doi: 10.1016/j.ejcts.2010.12.047. Epub 2011 Feb 21.
PubMed 21334911Vondrys D, Elliott MJ, McLaren CA, Noctor C, Roebuck DJ. First experience with biodegradable airway stents in children. Ann Thorac Surg. 2011 Nov;92(5):1870-4. doi: 10.1016/j.athoracsur.2011.07.042. Epub 2011 Oct 31.
PubMed 22051281Chin CS, Litle V, Yun J, Weiser T, Swanson SJ. Airway stents. Ann Thorac Surg. 2008 Feb;85(2):S792-6. doi: 10.1016/j.athoracsur.2007.11.051.
PubMed 18222219Korpela A, Aarnio P, Sariola H, Tormala P, Harjula A. Bioabsorbable self-reinforced poly-L-lactide, metallic, and silicone stents in the management of experimental tracheal stenosis. Chest. 1999 Feb;115(2):490-5. doi: 10.1378/chest.115.2.490.
PubMed 10027451Korpela A, Aarnio P, Sariola H, Tormala P, Harjula A. Comparison of tissue reactions in the tracheal mucosa surrounding a bioabsorbable and silicone airway stents. Ann Thorac Surg. 1998 Nov;66(5):1772-6. doi: 10.1016/s0003-4975(98)00763-2.
PubMed 9875787Saito Y, Minami K, Kobayashi M, Nakao Y, Omiya H, Imamura H, Sakaida N, Okamura A. New tubular bioabsorbable knitted airway stent: biocompatibility and mechanical strength. J Thorac Cardiovasc Surg. 2002 Jan;123(1):161-7. doi: 10.1067/mtc.2002.118503.
PubMed 11782770Freitag L, Ernst A, Unger M, Kovitz K, Marquette CH. A proposed classification system of central airway stenosis. Eur Respir J. 2007 Jul;30(1):7-12. doi: 10.1183/09031936.00132804. Epub 2007 Mar 28.
PubMed 17392320Hytych V, Horazdovsky P, Stehlik L, Pracharova S, Pohnan R, Lefnerova S, Vasakova M. Our own method of fixation of biodegradable tracheal stent. Bratisl Lek Listy. 2015;116(5):340-2. doi: 10.4149/bll_2015_064.
PubMed 25924646Stehlik L, Hytych V, Letackova J, Kubena P, Vasakova M. Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing. BMC Pulm Med. 2015 Dec 21;15:164. doi: 10.1186/s12890-015-0160-6.
PubMed 26690793Stehlik L, Guha D, Anandakumar S, Taskova A, Vasakova MK. Biodegradable tracheal stents: our ten-year experience with adult patients. BMC Pulm Med. 2024 May 15;24(1):238. doi: 10.1186/s12890-024-03057-y.
PubMed 38750487
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodegradable Stents in the Management of Stenoses of the Large Airways
- ClinicalTrials.gov ID
- NCT02620319
- Acronym / sponsor ID
- NT 14146-3/2013
- Conditions
- Tracheal Stenosis
- Keywords
- bronchoscopy, polydioxanone, absorbable implants, stents
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The protocol turned out to be not quite suitable for most patients. Apart from Thomayer's hospital, 2 other centers could not cooperate. The introduction of stents continued at the Thomayer Hospital. Publication of results is planned in 2024.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ludek StehlikUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, University Hospital Olomouc, University Hospital, Motol
- Study start
- May 2013
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to determine whether biodegradable polydioxanone stents are efficient in the treatment of adult patients with tracheobronchial stenoses.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biodegradable stent | Experimental | Device: SX-ELLA Stent DV Tracheal (DV Stent)endoscopic implantation of biodegradable airway stent, the SX-ELLA Stent DV Tracheal (DV Stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- stenoses of any origin which can be treated primarily surgically
- stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SX-ELLA Stent DV Tracheal (DV Stent)Also: DV StentThe 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. | Device | biodegradable stent |
Primary outcome
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).
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 21885070Novotny L, Crha M, Rauser P, Hep A, Misik J, Necas A, Vondrys D. Novel biodegradable polydioxanone stents in a rabbit airway model. J Thorac Cardiovasc Surg. 2012 Feb;143(2):437-44. doi: 10.1016/j.jtcvs.2011.08.002. Epub 2011 Aug 31.
- Background: PubMed 21334911Lischke R, Pozniak J, Vondrys D, Elliott MJ. Novel biodegradable stents in the treatment of bronchial stenosis after lung transplantation. Eur J Cardiothorac Surg. 2011 Sep;40(3):619-24. doi: 10.1016/j.ejcts.2010.12.047. Epub 2011 Feb 21.
- Background: PubMed 22051281Vondrys D, Elliott MJ, McLaren CA, Noctor C, Roebuck DJ. First experience with biodegradable airway stents in children. Ann Thorac Surg. 2011 Nov;92(5):1870-4. doi: 10.1016/j.athoracsur.2011.07.042. Epub 2011 Oct 31.
- Background: PubMed 18222219Chin CS, Litle V, Yun J, Weiser T, Swanson SJ. Airway stents. Ann Thorac Surg. 2008 Feb;85(2):S792-6. doi: 10.1016/j.athoracsur.2007.11.051.
- Background: PubMed 10027451Korpela A, Aarnio P, Sariola H, Tormala P, Harjula A. Bioabsorbable self-reinforced poly-L-lactide, metallic, and silicone stents in the management of experimental tracheal stenosis. Chest. 1999 Feb;115(2):490-5. doi: 10.1378/chest.115.2.490.
- Background: PubMed 9875787Korpela A, Aarnio P, Sariola H, Tormala P, Harjula A. Comparison of tissue reactions in the tracheal mucosa surrounding a bioabsorbable and silicone airway stents. Ann Thorac Surg. 1998 Nov;66(5):1772-6. doi: 10.1016/s0003-4975(98)00763-2.
- Background: PubMed 11782770Saito Y, Minami K, Kobayashi M, Nakao Y, Omiya H, Imamura H, Sakaida N, Okamura A. New tubular bioabsorbable knitted airway stent: biocompatibility and mechanical strength. J Thorac Cardiovasc Surg. 2002 Jan;123(1):161-7. doi: 10.1067/mtc.2002.118503.
- Background: PubMed 17392320Freitag L, Ernst A, Unger M, Kovitz K, Marquette CH. A proposed classification system of central airway stenosis. Eur Respir J. 2007 Jul;30(1):7-12. doi: 10.1183/09031936.00132804. Epub 2007 Mar 28.
- Results publication: PubMed 25924646Hytych V, Horazdovsky P, Stehlik L, Pracharova S, Pohnan R, Lefnerova S, Vasakova M. Our own method of fixation of biodegradable tracheal stent. Bratisl Lek Listy. 2015;116(5):340-2. doi: 10.4149/bll_2015_064.
- Results publication: PubMed 26690793Stehlik L, Hytych V, Letackova J, Kubena P, Vasakova M. Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing. BMC Pulm Med. 2015 Dec 21;15:164. doi: 10.1186/s12890-015-0160-6.
- Results publication: PubMed 38750487Stehlik L, Guha D, Anandakumar S, Taskova A, Vasakova MK. Biodegradable tracheal stents: our ten-year experience with adult patients. BMC Pulm Med. 2024 May 15;24(1):238. doi: 10.1186/s12890-024-03057-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludek Stehlik, MUDr. principal investigator
Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4
Miloslav Marel, Prof. MUDr. study director
Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital
Vitezslav Kolek, Prof. MUDr. study director
Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SX-ELLA Stent DV Tracheal (DV Stent) in people with Tracheal Stenosis, run by Ludek Stehlik at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620319, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.