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

NCT03111888 | Withdrawn DMC FDA Device

• 1 other identifier: gildea0217
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Outcome Measures

Primary Outcomes (2)

• Observe the outcomes associated with patient-specific airway implants.

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

  Up to 90 days following treatment

• Observe the outcomes associated with patient-specific airway implants.

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

  Up to 90 days following treatment

Study Arms (1)

Patient-Specific Tracheobronchial Stent

EXPERIMENTAL

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.

Device: Silicone Stent Airway Implant

Interventions

Silicone Stent Airway Implant DEVICE

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.

Patient-Specific Tracheobronchial Stent

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Custom Orthopaedic Solutions: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas R Gildea, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 13, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: March 8, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)