Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 5, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DEVICE

Patient-Specific Silicone Airway Stent

The Patient-Specific Airway Stent is a silicone stent indicated for use in adults that have stenosis of the airway. Current silicone stents have stock dimensions that do not conform to the patient's airway anatomy. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally design the stent to his/her desired dimensions. Finally, according to the physician's design, a patient-specific stent can be manufactured using additive manufacturing technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope.

Trial Locations (2)

44195

Pulmonary Medicine, Cleveland

55905

Mayo Clinic, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

collaborator

Mayo Clinic

OTHER

lead

VisionAir Solutions

INDUSTRY

NCT05050591 - Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent | Biotech Hunter | Biotech Hunter