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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
  • 18 to 80 years of age;
  • Capable and willing to give informed consent;
  • Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
  • Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy;

Subjects will be excluded from participating in this Study if they meet any of the following criteria prior to initiation of the endoscopic procedure:

  • Medical contraindication to bronchoscopy;
  • Ground glass opacity lesions on pre-procedure CT;
  • 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;
  • CT scan done over a month before the bronchoscopy 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.

Principal Investigator

Ganesh Krishna, MD, Palo Alto Medical Foundation

Sponsor

Auris Surgical Robotics, Inc.

Contact

John Tejeda, Enterprise Senior Director for Clinical Research
Taft Center for Clinical Research
650-691-4894
John_Tejeda@elcaminohealth.org

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