Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung (CSAir 1)
This study has been completed.
Sponsor:
CSA Medical, Inc.
Information provided by:
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00747773
First received: September 3, 2008
Last updated: May 27, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Device: CryoSpray Ablation System |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by CSA Medical, Inc.:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 21 |
| Study Start Date: | November 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: CryoSpray Ablation System
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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years of age
- Lobectomy planned based on clinical situation not related to this study.
- Deemed operable based on institutional criteria.
Exclusion Criteria:
- Pregnant or nursing
- Planning to sire a child while enrolled in the study
- Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
- Refusal or inability to give consent.
- Concurrent chemotherapy.
- Prior radiation therapy which involved the lungs
- Medical contraindication or potential problem that would preclude study participation
- Concurrent participation in other experimental studies
- Uncontrolled coagulopathy or bleeding diathesis
- Serious medical illness, including:
- Uncontrolled congestive heart failure
- Uncontrolled angina
- Myocardial infarction
- Cerebrovascular accident within 6 months prior to study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747773
Locations
| United States, Maryland | |
| Franklin Square Hospital Center | |
| Baltimore, Maryland, United States, 21237 | |
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
| Principal Investigator: | Willaim Krimsky, MD | PCCAB, Franklin Square Hospital Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Karen McKenzie Clinical Trials Project Manager, CSA Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00747773 History of Changes |
| Other Study ID Numbers: | 17-00008-00 |
| Study First Received: | September 3, 2008 |
| Last Updated: | May 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CSA Medical, Inc.:
|
Lung Cancer CryoPsray Ablation CSA therapy |
CSA treatment Lobectomy lung resection |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013