AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructiveNCT05050591

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

A study testing Patient-Specific Silicone Airway Stent in people with Pulmonary Disease, Chronic Obstructive, run by VisionAir Solutions at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of the trial is to establish a method, material, and patient-specific stent design that will last longer, fit better, and cause less trauma to the airway and the patient. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Patient-Specific Silicone Airway Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
5 Aug 2021to Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Patients will be considered for study inclusion if they have a clinical need for airway stenting defined by prior evidence of existing stents that have at least temporarily improved symptoms, but now suffer from stent complications; or those for whom a stent would be offered if an appropriate size and shape was available. Subjects must meet the following inclusion/exclusion criteria to be eligible for the study.

  • Understand and voluntarily sign an informed consent form.
  • Patients must be at least 22 years of age
  • Patients must be able to undergo routine non-contrast CT scans of the chest
  • Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
  • The patients must have at least an expected 6 month survival.
  • Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
  • Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design
  • Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS (See Section 5.4 of this protocol for envelope)

Exclusion Criteria: Patients may be excluded if management of the airway problem can be safely and effectively treated with commercially available stents (SOC), non-stenting techniques, or surgical options.

  • Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
  • Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES) or 6 weeks following bare metal coronary stent)
  • Unstable cardiac disease
  • Allergy to silicone
  • Stenting to manage vascular compression syndromes.
  • Multi-drug resistant bacterial or fungal chronic infections
  • Emergent/urgent clinically indicated stent.
  • Chronic/permanent mechanical ventilation.
  • Pure Excessive Dynamic Airway Collapse (EDAC) patients.
  • Pure Pulmonary Resistance (Rp) patients.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Pulmonary Medicine

    Cleveland, Ohio, 44195

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant

The goal of the trial is to establish a method, material, and patient-specific stent design that will last longer, fit better, and cause less trauma to the airway and the patient.

Read the detailed description

This is a prospective trial of the clinical utility of a patient-specific silicone stent implant for patients with complex airway disease, requiring an airway stent. The aim of this study is to observe the outcomes associated with the implants. Current stents have been suboptimal for treating benign stenosis of the airway and we are seeking to create a better treatment option. We hypothesize, based on the previous compassionate-use cases, that placing a patient-specific silicone stent will effectively alleviate symptoms associated with stenosis of the airway. The main measure of effectiveness will be patient-reported outcomes.

The implant will occur on Day 0 and TDI and formal assessment for AEs will occur on Day 1.

Patients will be seen on Day 60 +/- 14 days for formal assessment including TDI and QOL, dynamic CT, and a bronchoscopy procedure will be performed as per our usual standard of care. Additional ascertainments of the TDI and QOL measurements will occur at 90 and 180 days after implantation.

A standardized assessment of the stent as well and any modification or any other treatments will be recorded. Washing for cultures will also be done per standard of care during any bronchoscopy.

Being tested
Patient-Specific Silicone Airway Stent
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-Specific Silicone Airway StentDevice

    The Patient-Specific Airway Stent is a silicone stent indicated for use in adults that have stenosis of the airway. Current silicone stents have stock dimensions that do not conform to the patient's airway anatomy. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally design the stent to his/her desired dimensions. Finally, according to the physician's design, a patient-specific stent can be manufactured using additive manufacturing technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope.

Study groups in NCT05050591
Study groupRoleWhat they receive
Single-Arm StudyExperimentalThis is a prospective trial of the clinical utility of a patient-specific silicone stent implant for patients with complex airway disease, requiring an airway stent. The aim of this study is to observe the outcomes associated with the implants. Current stents have been suboptimal for treating benign stenosis of the airway and we are seeking to create a better treatment option. We hypothesize, based on the previous compassionate-use cases, that placing a patient-specific silicone stent will effectively alleviate symptoms associated with stenosis of the airway. The main measure of effectiveness will be patient-reported outcomes.
Receives: Device: Patient-Specific Silicone Airway Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day -1

  2. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day 1

  3. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day 14

  4. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day 30

  5. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day 60

  6. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day 90

  7. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Measured: Day 180

  8. Ability to implant stent

    Number of patients able to successfully receive patient-specific stent

    Measured: Day 0

Secondary outcomes (11)

  1. SGRQ

    Change in Quality of Life over course of study

    Measured: Day -1

  2. SGRQ

    Change in Quality of Life over course of study

    Measured: Day 60

  3. SGRQ

    Change in Quality of Life over course of study

    Measured: Day 90

  4. SGRQ

    Change in Quality of Life over course of study

    Measured: Day 180

  5. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 0

  6. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 1

  7. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 14

  8. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 30

  9. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 60

  10. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 90

  11. CTCAE

    Number of adverse event(s) over course of study

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start5 Aug 2021
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

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
Model description
Prospective observational study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05050591
Sponsor's protocol ID
21-681
Status last verified
Jan 2025
First submitted
7 Sep 2021
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor. Any investigator involved with this study is obligated to provide the sponsor with complete test results and all data derived from the study.

Publications

  • Saad CP, Murthy S, Krizmanich G, Mehta AC. Self-expandable metallic airway stents and flexible bronchoscopy: long-term outcomes analysis. Chest. 2003 Nov;124(5):1993-9. doi: 10.1378/chest.124.5.1993.

    PubMed 14605078

  • Gildea TR, Downie G, Eapen G, Herth F, Jantz M, Freitag L. A prospective multicenter trial of a self-expanding hybrid stent in malignant airway obstruction. Journal of Bronchology 2008;15:221-4

  • FDA public health notification: complications from metallic tracheal stents in patients with benign airway disorders. 2005. Anonymous . (, at www.fda.gov/cdrh/safety/072905-tracheal.html)

  • Gershman AJ, Gildea TR, Mehta AC. Complication of metallic stent in lung transplant dehiscence. J Heart Lung Transplant. 2006 Jun;25(6):742-3. doi: 10.1016/j.healun.2006.02.008. Epub 2006 May 2. No abstract available.

    PubMed 16730586

  • Choudhary C, Bandyopadhyay D, Salman R, Gildea T, Mehta A. Broncho-vascular fistulas from self-expanding metallic stents: A retrospective case review. Ann Thorac Med. 2013 Apr;8(2):116-20. doi: 10.4103/1817-1737.109830.

    PubMed 23741275

  • Breen DP, Dutau H. On-site customization of silicone stents: towards optimal palliation of complex airway conditions. Respiration. 2009;77(4):447-53. doi: 10.1159/000205396. Epub 2009 Feb 26.

    PubMed 19246883

  • Alraiyes AH, Machuzak MS, Gildea TR. Intussusception technique of intrabronchial silicone stents: description of technique and a case report. J Bronchology Interv Pulmonol. 2013 Oct;20(4):342-4. doi: 10.1097/LBR.0000000000000009.

    PubMed 24162120

  • Tendulkar RD, Fleming PA, Reddy CA, Gildea TR, Machuzak M, Mehta AC. High-dose-rate endobronchial brachytherapy for recurrent airway obstruction from hyperplastic granulation tissue. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):701-6. doi: 10.1016/j.ijrobp.2007.07.2324. Epub 2007 Sep 29.

    PubMed 17904764

  • Kumar A, Alraiyes AH, Gildea TR. Amniotic Membrane Graft for Bronchial Anastomotic Dehiscence in a Lung Transplant Recipient. Ann Am Thorac Soc. 2015 Oct;12(10):1583-6. doi: 10.1513/AnnalsATS.201505-265CC. No abstract available.

    PubMed 26448355

  • Dutau H, Cavailles A, Sakr L, Badier M, Gaubert JY, Boniface S, Doddoli C, Thomas P, Reynaud-Gaubert M. A retrospective study of silicone stent placement for management of anastomotic airway complications in lung transplant recipients: short- and long-term outcomes. J Heart Lung Transplant. 2010 Jun;29(6):658-64. doi: 10.1016/j.healun.2009.12.011. Epub 2010 Feb 4.

    PubMed 20133161

  • Fortin M, MacEachern P, Hergott CA, Chee A, Dumoulin E, Tremblay A. Self-expandable metallic stents in nonmalignant large airway disease. Can Respir J. 2015 Jul-Aug;22(4):235-6. doi: 10.1155/2015/246509.

    PubMed 26252535

  • Gildea TR, Murthy SC, Sahoo D, Mason DP, Mehta AC. Performance of a self-expanding silicone stent in palliation of benign airway conditions. Chest. 2006 Nov;130(5):1419-23. doi: 10.1378/chest.130.5.1419.

    PubMed 17099019

Questions about this trial

What is this clinical trial studying?

A study testing Patient-Specific Silicone Airway Stent in people with Pulmonary Disease, Chronic Obstructive, run by VisionAir Solutions at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Baseline Dyspnea Index/Transitional Dyspnea Index (time frame: Day -1). The study lists 8 primary outcomes in all. 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 NCT05050591, which also lists 12 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 5 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in