RejuvenAir System Lobectomy Version 2
Research type
Research Study
Full title
A Prospective Study of RejuvenAir™ System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung
IRAS ID
155588
Contact name
Pallav Shah
Contact email
Sponsor organisation
CSA Medical, Inc.
Clinicaltrials.gov Identifier
Research summary
The study is to demonstrate the feasibility and safety of the RejuvenAir™ System when utilized in the segmental region of the lung (which equates to the most distal extent of the anticipated chronic bronchitis treatment pathway) in subjects who are scheduled to undergo lobectomy/pneumonectomy for peripheral lung lesions suspicious for or known to be cancer. Secondarily, we wish to understand the histological outcome of the treatment area in the airways in humans. Data from this study will be used to support a larger clinical trial intending to treat subjects with symptomatic Chronic Bronchitis.
Once consented, Subjects will be scheduled for a bronchoscopic procedure using the RejuvenAir System in the same surgical session as the surgery. So no follow up is required, except for the capture of serious adverse events. If the planned resection surgery is delayed, the subjects will require follow-up until the lung surgery takes place.
During the actual procedure the RejuvenAir catheter will be passed into the working channel of the bronchoscope and directed to the bronchial location to be treated. The catheter will then be centralized within the airway and the physician will activate the specified metered dose of cryogen. There will be one dose per segmental or lobar branch. Dosing will be limited to a maximum of two fully completed RejuvenAir System doses per subject. Following the subject’s surgical procedure, retrieved specimens for study evaluation will be collected and processed according to the protocol.
The RejevenAir is 4th Generation Technology. The three previous iterations that form the basis of the RejuvenAir device have been cleared by the FDA through the 510K process. The system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area. It delivers the liquid nitrogen via a small, low pressure, closed round tip radial catheter capable of retro flexing.REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1176
Date of REC Opinion
21 Jul 2014
REC opinion
Favourable Opinion