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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CryoSpray Ablation System | Device | CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications" (K070893). As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold |
| Measure | Description | Time Frame |
|---|---|---|
| The primary safety endpoint for this study is patient safety | Throughout study | |
| The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients | Throughout Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willaim Krimsky, MD | PCCAB, Franklin Square Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19664781 | Result | Krimsky WS, Broussard JN, Sarkar SA, Harley DP. Bronchoscopic spray cryotherapy: assessment of safety and depth of airway injury. J Thorac Cardiovasc Surg. 2010 Mar;139(3):781-2. doi: 10.1016/j.jtcvs.2009.03.051. Epub 2009 Aug 6. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 9, 2014 | |
| Reset | Jul 9, 2014 | |
| Release | Feb 2, 2015 | |
| Reset | Feb 14, 2015 | |
| Release | Jun 4, 2015 | |
| Reset | Jul 2, 2015 | |
| Release | Jul 2, 2015 | |
| Reset | Jul 29, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 9, 2014 | Jul 9, 2014 | |||
| Feb 2, 2015 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Feb 14, 2015 |
| Jun 4, 2015 | Jul 2, 2015 |
| Jul 2, 2015 | Jul 29, 2015 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |