RejuvenAir Lobectomy for Safety and Histology
Condition: Lung Neoplasms; Pulmonary Neoplasms
MeSH terms: Neoplasms; Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days
      prior to prescheduled lung resection in Subjects requiring lobectomy for removal of
      peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that
      will be removed, distal to the anticipated margin of resection. Treatment should be at least
      1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will
      be inspected via bronchoscopy at the time of thoracotomy, and examined histologically
      following surgical resection. Subject participation will be from 1 to 90 days and enrollment
      is anticipated to take 3 months. Subject having a RejuvenAir procedure and not going on to a
      resection for any reason will be followed for a maximum of 90 days for safety and undergo
      bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.
    

Detailed description: 
      The study is a prospective, open label, single arm, single center study. The objective is to
      study the safety of the RejuvenAir System in a population of subjects who are scheduled to
      undergo a planned lobectomy. A secondary objective is to determine the histological effects
      of RejuvenAir System treatment in the airways. The Primary Endpoint is Safety as measured by
      occurrence of serious adverse events related to metered dose radial spray cryotherapy
      treatment performed prior to scheduled lobectomy surgery. The patient population intended to
      participate in this study are subjects scheduled to undergo lobectomy for peripheral lung
      lesions suspicious for or known to be cancer. Secondarily, this will enable an understanding
      of the histological characteristics and healing outcomes post-treatment in the airways, which
      will be resected. CSA Medical has conducted bench and animal studies that support the use of
      the RejuvenAir System as sufficiently safe and effective to warrant advancing the product
      into this primary safety study in patients presenting for consideration of lobectomy. Such
      patients provide a safe population to further the clinical evaluation of the system in that
      these subjects will receive their lobectomy or procedure 2 to 14 days following delivery of
      their metered liquid nitrogen treatment. At the time of their metered liquid nitrogen
      treatment they will be in an operating room setting with their thoracic surgeon in
      attendance. It is anticipated that subjects who agree to participate in this study will have
      the metered liquid nitrogen treatment at the time of evaluation of their lung lesion. This
      evaluation will include bronchoscopy with ultrasound for evaluation of their lymph nodes
      prior to the planned surgical resection of their lung abnormality.
    

Intervention name(s): RejuvenAir
Intervention type(s): Device
Intervention description(s): RejuvenAir
Other intervention name(s): RejuvenAir™ System Radial Spray Cryotherapy
Intervention model: Single Group Assignment
Intervention model description: RejuvenAir
Masking: None (Open Label)
Primary purpose: Other
Keywords: lobectomy; spray cryotherapy; lung cancer