None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility of the Auris endoscopy system in diagnostic pulmonary endoscopy. The Auris endoscopy system is a system to guide tools to predetermined points within the airways of the lung in order to extract tissue and specimens for evaluation of suspected malignant lung lesions.
Interventions
The Auris bronchoscopic system guides bronchoscopic tools within the airways to enable biopsy of specimens from suspected malignant lesions using automated mechanical user controls.
The patients will be selected based on the need for a lung biopsy procedure for suspected malignant lesions. A biopsy procedure will be required for this patient regardless of the technique to be used. These techniques can vary from a bronchoscopic approach to a transthoracic (through the chest wall) needle approa
The Auris bronchoscopic system guides bronchoscopic tools within the airways to enable biopsy of specimens from suspected malignant lesions using automated mechanical user controls. The patients will be selected based on the need for a lung biopsy procedure for suspected malignant lesions. A biopsy procedure will be required for this patient regardless of the technique to be used. These techniques can vary from a bronchoscopic approach to a transthoracic (through the chest wall) needle approach. Most often the patient will only need one procedure to evaluate the tissue obtained through the biopsy.
Sponsors
Auris, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject age above 18 yr of age Signed informed consent provided A negative pregnancy test in a woman with child-bearing potential Lesions in the central airways or peripheral lesions with bronchus sign suspected of malignancy
Exclusion criteria
Medical contraindication to bronchoscopy Participation in any other clinical trial 30 days before and throughout the duration of the study Uncontrolled or irreversible coagulopathy Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test. Inability to give consent
Outcome results
None listed