RejuvenAir™ System Lobectomy Safety and Histology Study
Condition: Lung Neoplasms; Airway Obstruction; Lung Cancer
MeSH terms: Lung Neoplasms; Airway Obstruction
Study type: Interventional

Summary: 
      Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System
      radial spray cryotherapy is a novel procedure being developed as a treatment for conditions
      associated with abnormal bronchial function, such as chronic bronchitis. The development of
      appropriate reliable equipment, definition of therapeutic parameters, and an understanding of
      the tissue effects of treatment have been established through animal studies. This clinical
      study is being undertaken to assess the feasibility and safety of the application of a radial
      metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in
      human airways. The study design is prospective, open label, single arm multi-center study
      that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The
      Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0
      to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or
      pneumonectomy 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
      60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to
      last approximately 10 months.
    

Detailed description: 
      The patient population intended to participate in this study are subjects scheduled to
      undergo lobectomy/pneomonectomy for peripheral lung lesions suspicious for or known to be
      cancer. The intention is that the spray cryotherapy dosing will be performed at the same
      surgical session as the intended surgery. Bronchoscopy is routinely performed just prior to
      the start of the lung resection and it is anticipated that the spray cryotherapy dose will be
      delivered at that time. Care will be taken to avoid administration of the spray cryotherapy
      dose at or near the surgical resection margin or near the lung lesion itself.

      A secondary endpoint beyond the safety and ease of delivery of the spray cryotherapy dose
      will be an analysis of the local tissue effect of the spray cryotherapy dose. Given that this
      area will reside within the anticipated resected surgical specimen, the treatment site will
      be inspected for evidence of depth of tissue effect using routine hematoxylin and eosin
      staining and light microscopy evaluation.
    

Intervention name(s): RejuvenAir™ Radial Spray Cryotherapy
Intervention type(s): Device
Intervention description(s): Metered dose radial spray cryotherapy treatment
Intervention model: Single Group Assignment
Intervention model description: RejuvenAir
Masking: None (Open Label)
Primary purpose: Device Feasibility