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Active, not recruitingNCT05050591Updated Feb 5, 2025

Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

An interventional study of Patient-Specific Silicone Airway Stent in Pulmonary Disease, Chronic Obstructive, sponsored by VisionAir Solutions. Active, not recruiting at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by VisionAir Solutions · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

This is the only study on the registry with VisionAir Solutions as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Single-Arm Study

    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.

    Device: Patient-Specific Silicone Airway Stent

Interventions

  • DevicePatient-Specific Silicone Airway Stent

    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.

06

What researchers measure

Primary outcomes

  1. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day -1

  2. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day 1

  3. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day 14

  4. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day 30

  5. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day 60

  6. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day 90

  7. Baseline Dyspnea Index/Transitional Dyspnea Index

    Change in BDI/TDI over course of study

    Time frame: Day 180

  8. Ability to implant stent

    Number of patients able to successfully receive patient-specific stent

    Time frame: Day 0

Secondary outcomes

  1. SGRQ

    Change in Quality of Life over course of study

    Time frame: Day -1

  2. SGRQ

    Change in Quality of Life over course of study

    Time frame: Day 60

  3. SGRQ

    Change in Quality of Life over course of study

    Time frame: Day 90

  4. SGRQ

    Change in Quality of Life over course of study

    Time frame: Day 180

  5. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 0

  6. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 1

  7. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 14

  8. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 30

  9. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 60

  10. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 90

  11. CTCAE

    Number of adverse event(s) over course of study

    Time frame: Day 180

07

Study locations

2 sites
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Pulmonary Medicine
    Cleveland, Ohio 44195, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05050591
Lead sponsor
VisionAir Solutions
Collaborators
The Cleveland Clinic, Mayo Clinic
Responsible party
Sponsor
First posted
Sep 20, 2021
Start date
Aug 5, 2021
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Feb 5, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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