The Canadian and European Safety Studies (NCT02483052 and NCT02106143) will be showcased in an oral presentation at the WCBIP Conference on Wednesday, May 11, 2016 in Florence, Italy. It will be included in the session titled: Session 88: Bronchoscopy Meets COPD and Asthma.
"These studies represent a major step in our development of the RejuvenAir® System as the data supports the safety of delivering this therapy at the deepest lung segment in our anticipated treatment plan," said Ellen Sheets, MD, CEO of CSA Medical.
Chronic Bronchitis is a subset of Chronic Obstructive Pulmonary Disease (COPD). A chronic bronchitis diagnosis is defined by cough with productive sputum of three months duration for two consecutive years. In addition to a chronic inflammation, cough and increased production of mucus, chronic bronchitis may or may not present with obstruction/partially blocked airways due to swelling and excess mucus in the bronchi, or shortness of breath (dyspnea).
About the Studies
The European Safety Study (NCT02106143)
David Breen, MD at Galway University Hospital and Dirk-Jan Slebos, MD at University Medical Center Groningen enrolled patients who were scheduled within 60 days for a planned lobectomy or pneumonectomy. Eleven patients underwent two sprays per treatable location within the lobe intended for resection. The objectives were to demonstrate the feasibility and safety of delivery of a specific cryospray therapy dose using the RejuvenAir® System, and to understand the histologic outcome of the treatment area in the airway in humans.
The Canadian Safety Study (NCT02483052)
Kashif Irshad, MDCM, MSc at William Osler Health System in Brampton, Ontario, Canada enrolled patients who were scheduled for lobectomy within 2 - 90 days from date of study treatment. Four patients underwent two sprays per treatable location within the lobe intended for resection. The objectives were to demonstrate safety and to determine the delayed histological effects of the RejuvenAir® System treatment in the human airway.
About CSA Medical
CSA Medical, Inc. develops and manufactures a proprietary interventional spray cryotherapy technology platform utilizing unique properties of liquid nitrogen spray delivered by a software driven device with specialty catheters that enable delivery of spray cryogen inside the body to flash freeze and destroy unwanted tissue allowing for a rejuvenative pattern of healing. CSA manufactures and distributes this technology in the USA as the truFreeze® system which is currently used to ablate unwanted benign and malignant tissue. The RejuvenAir System is currently under clinical investigation and is not commercially available.
To learn more about our technology as well as recent management team updates, please visit http://csamedical.com/.
PRLog ID: www.prlog.org/12543449
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SOURCE CSA Medical