Clinical trial NCT00747773: Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Official title: A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Keywords: Lung Cancer
CryoPsray Ablation
CSA therapy
CSA treatment
Lobectomy
lung resection
Lead sponsor: CSA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

Primary outcomes:
measure: The primary safety endpoint for this study is patient safety
timeFrame: Throughout study
measure: The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients
timeFrame: Throughout Study
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
Study officials:
affiliation: PCCAB, Franklin Square Hospital Center
name: Willaim Krimsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.