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

NCT03111888 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-03-08

No results posted yet for this study

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

Interventions

DEVICE

Silicone Stent Airway Implant

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.

Sponsors & Collaborators

  • Custom Orthopaedic Solutions

    collaborator UNKNOWN

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Thomas R Gildea, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-12-31
Completion
2019-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111888 on ClinicalTrials.gov