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Bronchoscopic Lung Biopsy enhancement with LungVision device

Study Type/Phase: Observational
Enrollment Status: Recruiting

This research study involves the LungVision device, a device that includes hardware and software (like a computer) and collects data during lung biopsy procedures. These lung biopsy procedures provide the doctors with the necessary data to diagnose potential lung diseases. The purpose of this study is to collect the data from these procedures in order to improve and optimize the design of the LungVision device. Participating in this study will not change a patient’s clinical care and the performance of the lung biopsy procedure.

The LungVision study device is only approved as an investigational device and serves as an extra addition that does not increase risk or length of the procedure. Prior to the procedure, the device will be connected to the imaging equipment in the biopsy room. However, since the device is not yet optimized, study doctor will be using the standard equipment which would normally be used for the lung biopsy procedure.

Up to 150 subjects may be enrolled into this multi-center research study.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Patients with CT detected peripheral lung lesions which are scheduled to undergo diagnostic bronchoscopy with biopsy.
  • Available CT image with slice thickness ≤1.5 mm
  • Male and female > 18 years of age
  • Able and willing to comply with study procedures and provide written informed consent.
  • Patients with any prior lung resection or lung transplantation
  • Participation in any other study which may interfere with quality data collection

Principal Investigator

Dr. Ganesh Krishna

Sponsor

Body Vision Medical LTD

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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