Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

NCT05050591 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 21-681
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• SGRQ

  Day -1

• SGRQ

  Day 60

• SGRQ

  Day 90

• SGRQ

  Day 180

• CTCAE

  Day 0

Study Arms (1)

Single-Arm Study

EXPERIMENTAL

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

Patient-Specific Silicone Airway Stent DEVICE

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.

Single-Arm Study

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• VisionAir Solutions: lead
• The Cleveland Clinic: collaborator
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Pulmonary Medicine

Cleveland, Ohio, 44195, United States

Location

Related Publications (12)

• 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.

  PMID: 14605078 BACKGROUND

• 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

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 16730586 BACKGROUND

• 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.

  PMID: 23741275 BACKGROUND

• 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.

  PMID: 19246883 BACKGROUND

• 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.

  PMID: 24162120 BACKGROUND

• 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.

  PMID: 17904764 BACKGROUND

• 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.

  PMID: 26448355 BACKGROUND

• 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.

  PMID: 20133161 BACKGROUND

• 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.

  PMID: 26252535 BACKGROUND

• 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.

  PMID: 17099019 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective observational study

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 20, 2021
• Study Start: August 5, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

US (2)