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Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent
N/A
Waitlist Available
Research Sponsored by VisionAir Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 180
Awards & highlights
No Placebo-Only Group
Summary
This trialaims to find a better stent design that fits better, lasts longer and is less harmful to patients.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ability to implant stent
Baseline Dyspnea Index/Transitional Dyspnea Index
Secondary study objectives
CTCAE
SGRQ
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-Arm StudyExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
VisionAir SolutionsLead Sponsor
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,452 Total Patients Enrolled
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,066,104 Total Patients Enrolled