A single-center, prospective, single arm study to evaluate the performance of the Auris Robotic Endoscopy System (ARES) for bronchoscopic procedures.
Study Type/Phase: Feasibility
Status: Not Recruiting
This feasibility study is conducted to evaluate the performance of the novel robotic endoscopy system during bronchoscopy procedures.
The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Although there are alternative techniques available such as surgical biopsy, patients might be at increased risk. Also, diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Therefore, there is an increased need for minimally invasive tissue diagnosis of these lesions.
This system is intended to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways. In the pre-clinical settings, the system has shown promise in addressing the limitations of currently available bronchoscopic approaches in assessment of suspicious peripheral lung lesions. Subjects will be asked to participate in a clinical research study if they are candidates for bronchoscopy and if they meet pre-specified inclusion/exclusion criteria. The system is not currently commercially available.
This is a single-center, prospective, single arm study.
Speak with your doctor to determine whether you meet the following criteria for participation in this study.
|Inclusion Criteria||Exclusion Criteria|
Subjects will be excluded from participating in this Study if they meet any of the following criteria prior to initiation of the endoscopic procedure:
Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient’s best interest.