Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Patient-Specific Silicone Airway Stent

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day -1
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day 1
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day 14
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day 30
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day 60
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day 90
Baseline Dyspnea Index/Transitional Dyspnea Index	Change in BDI/TDI over course of study	Day 180
Ability to implant stent	Number of patients able to successfully receive patient-specific stent	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SGRQ	Change in Quality of Life over course of study	Day -1
SGRQ	Change in Quality of Life over course of study	Day 60
SGRQ	Change in Quality of Life over course of study	Day 90
SGRQ	Change in Quality of Life over course of study	Day 180
CTCAE	Number of adverse event(s) over course of study	Day 0
CTCAE	Number of adverse event(s) over course of study	Day 1
CTCAE	Number of adverse event(s) over course of study	Day 14
CTCAE	Number of adverse event(s) over course of study	Day 30
CTCAE	Number of adverse event(s) over course of study	Day 60
CTCAE	Number of adverse event(s) over course of study	Day 90
CTCAE	Number of adverse event(s) over course of study	Day 180

Collaborators and Investigators

• Sponsor: VisionAir Solutions
• Collaborators: Mayo Clinic; The Cleveland Clinic

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 21-681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No