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Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Specific Silicone Airway Stent
Sponsored by
VisionAir Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo ClinicRecruiting
  • Pulmonary MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Arm Study

Arm 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.

Outcomes

Primary Outcome Measures

Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Baseline Dyspnea Index/Transitional Dyspnea Index
Change in BDI/TDI over course of study
Ability to implant stent
Number of patients able to successfully receive patient-specific stent

Secondary Outcome Measures

SGRQ
Change in Quality of Life over course of study
SGRQ
Change in Quality of Life over course of study
SGRQ
Change in Quality of Life over course of study
SGRQ
Change in Quality of Life over course of study
CTCAE
Number of adverse event(s) over course of study
CTCAE
Number of adverse event(s) over course of study
CTCAE
Number of adverse event(s) over course of study
CTCAE
Number of adverse event(s) over course of study
CTCAE
Number of adverse event(s) over course of study
CTCAE
Number of adverse event(s) over course of study
CTCAE
Number of adverse event(s) over course of study

Full Information

First Posted
September 7, 2021
Last Updated
October 14, 2022
Sponsor
VisionAir Solutions
Collaborators
The Cleveland Clinic, Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05050591
Brief Title
Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent
Official Title
Study for Evaluating the Clinical Effectiveness of 3D Printing for a Patient-specific Silicone Stent Airway Implant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
June 17, 2023 (Anticipated)
Study Completion Date
June 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionAir Solutions
Collaborators
The Cleveland Clinic, Mayo Clinic

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm Study
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Patient-Specific Silicone Airway Stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day -1
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day 1
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day 14
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day 30
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day 60
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day 90
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Description
Change in BDI/TDI over course of study
Time Frame
Day 180
Title
Ability to implant stent
Description
Number of patients able to successfully receive patient-specific stent
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
SGRQ
Description
Change in Quality of Life over course of study
Time Frame
Day -1
Title
SGRQ
Description
Change in Quality of Life over course of study
Time Frame
Day 60
Title
SGRQ
Description
Change in Quality of Life over course of study
Time Frame
Day 90
Title
SGRQ
Description
Change in Quality of Life over course of study
Time Frame
Day 180
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 0
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 1
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 14
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 30
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 60
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 90
Title
CTCAE
Description
Number of adverse event(s) over course of study
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
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.
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Cox
Phone
507-284-9946
Email
Cox.Thomas@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ryan Kern, MD
Facility Name
Pulmonary Medicine
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Gildea, MD
Phone
216-224-3820
Email
gildeat@ccf.org
First Name & Middle Initial & Last Name & Degree
Sai Conjeevaram, MPH
Phone
216-445-5947
Email
conjeea@ccf.org
First Name & Middle Initial & Last Name & Degree
Thomas Gildea, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.
Citations:
PubMed Identifier
14605078
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
16730586
Citation
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.
Results Reference
background
PubMed Identifier
23741275
Citation
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.
Results Reference
background
PubMed Identifier
19246883
Citation
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.
Results Reference
background
PubMed Identifier
24162120
Citation
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.
Results Reference
background
PubMed Identifier
17904764
Citation
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.
Results Reference
background
PubMed Identifier
26448355
Citation
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.
Results Reference
background
PubMed Identifier
20133161
Citation
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.
Results Reference
background
PubMed Identifier
26252535
Citation
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.
Results Reference
background
PubMed Identifier
17099019
Citation
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.
Results Reference
background

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Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

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