Clinical trial NCT03111888: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Emphysema
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Custom Orthopaedic Solutions
First posted: 2017-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.
2. Patients must be at least 18 years of age
3. Patients must be able to undergo routine non-contrast CT scans of the chest
4. Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
5. The patients must have at least an expected 6 month survival.
6. 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.
7. 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
8. Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS

Exclusion Criteria:

1. Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
2. 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)
3. Unstable cardiac disease
4. Allergy to silicone
5. Stenting to manage vascular compression syndromes.
6. Multi-drug resistant bacterial or fungal chronic infections
7. Emergent/urgent clinically indicated stent.
8. Chronic/permanent mechanical ventilation.

Primary outcomes:
measure: Observe the outcomes associated with patient-specific airway implants.
timeFrame: Up to 90 days following treatment
measure: Observe the outcomes associated with patient-specific airway implants.
timeFrame: Up to 90 days following treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Thomas R Gildea, MD
role: PRINCIPAL_INVESTIGATOR
References: