Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung (CSAir 1)
The purpose of this study is to evaluate the feasibility and general safety in the human airway as well as assess the safety and depth and area of treatment using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (FFB) using surgical resection specimens from patients undergoing lobectomy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung|
- The primary safety endpoint for this study is patient safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Device: CryoSpray Ablation System
The primary endpoints for this study are patient safety and the histological effects of cryospray therapy in lobectomy patients.
The proposed study is a single center study to evaluate the safety and treatment effect of sprayed liquid nitrogen through a catheter via FFB using surgical resection specimens from patients undergoing lobectomy.
|United States, Maryland|
|Franklin Square Hospital Center|
|Baltimore, Maryland, United States, 21237|
|Principal Investigator:||Willaim Krimsky, MD||PCCAB, Franklin Square Hospital Center|