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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Emphysema

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Silicone Stent Airway Implant

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

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

Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Patients must be at least 18 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

Exclusion Criteria:

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.

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient-Specific Tracheobronchial Stent

Arm Description

Observe and document the ability of a patient-specific tracheobronchial stent to improve a patient's quality of life and symptoms associated with airway stenosis.

Outcomes

Primary Outcome Measures

Observe the outcomes associated with patient-specific airway implants.

Measure Quality of Life Index through Baseline Dyspnea Index, a validated survey tool

Observe the outcomes associated with patient-specific airway implants.

Measure Quality of Life Index through Transitional Dyspnea Index, a validated survey tool

Secondary Outcome Measures

Full Information

NCT ID

NCT03111888

First Posted

April 4, 2017

Last Updated

March 6, 2018

Sponsor

The Cleveland Clinic

Collaborators

Custom Orthopaedic Solutions

1. Study Identification

Unique Protocol Identification Number

NCT03111888

Brief Title

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

Official Title

Small Feasibility 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

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Investigator decision

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

Custom Orthopaedic Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of the small feasibility trial is to establish a method, material, and patient-specific design that is superior to what is in use today. The first round of patients are well known to the physician investigator and are familiar with the problem that is being resolved. The end goal of the project is to create a new patient-specific design that will last longer, fit better, and cause less trauma to the airway and the patient.

Detailed Description

Subjects will be selected from physician investigator's clinical practice where patients have had failure of current stenting procedures to achieve an adequate clinical outcome. A routine CT scan of the chest is required on all individuals going through the procedure for stent placement (rigid bronchoscopy). The physician investigator will use this CT scan to measure and build a patient-specific stent or modify existing stents to fit the specific need.

6. Conditions and Keywords

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

Pulmonary Disease, Chronic Obstructive, Emphysema

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient-Specific Tracheobronchial Stent

Arm Type

Experimental

Arm Description

Observe and document the ability of a patient-specific tracheobronchial stent to improve a patient's quality of life and symptoms associated with airway stenosis.

Intervention Type

Device

Intervention Name(s)

Silicone Stent Airway Implant

Intervention Description

The Patient-Specific Tracheobronchial Stent is a silicone stent indicated for use in adults that have stenosis of the airway. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally build the stent to his/her desired dimensions. According to the physician's design, a patient-specific stent can be manufactured using rapid prototyping 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

Observe the outcomes associated with patient-specific airway implants.

Description

Measure Quality of Life Index through Baseline Dyspnea Index, a validated survey tool

Time Frame

Up to 90 days following treatment

Title

Observe the outcomes associated with patient-specific airway implants.

Description

Measure Quality of Life Index through Transitional Dyspnea Index, a validated survey tool

Time Frame

Up to 90 days following treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Understand and voluntarily sign an informed consent form. Patients must be at least 18 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas R Gildea, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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