Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Airway Obstruction

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Respiratory Insufficiency

Respiration Disorders

Subjects will receive Rejuvenair Radial SCT prior to lobectomy.

Metered dose radial spray cryotherapy treatment

RejuvenAir™ Radial Spray Cryotherapy

David Breen, MD

Pallav Shah, MD

Dirk-Jan Slebos, MD

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.

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.

RejuvenAir™ System Lobectomy Safety and Histology Study

A Prospective Study of RejuvenAir™ System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung

Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy or pneumonectomy surgery

Description of depth of histological treatment effect per specified treatment dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RejuvenAir™ System Lobectomy Safety and Histology Study	NCT02106143	Lung Neoplasms Airway Obstruct... Lung Cancer	RejuvenAir™ Rad...	21 Years - 75 Years	CSA Medical, Inc.
RejuvenAir™ System Lobectomy Safety and Histology Study	NCT02106143	Lung Neoplasms Airway Obstruct... Lung Cancer	RejuvenAir™ Rad...	21 Years - 75 Years	CSA Medical, Inc.

Spots Global Cancer Trial Database for rejuvenair™ radial spray cryotherapy