A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
18 Years
N/A
Both
Lung Cancer
Trial Information
A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary safety endpoint for this study is patient safety
Outcome Time Frame:
Throughout study
Safety Issue:
Yes
Principal Investigator
Willaim Krimsky, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
PCCAB, Franklin Square Hospital Center
Authority:
United States: Institutional Review Board
Study ID:
17-00008-00
NCT ID:
NCT00747773
Start Date:
November 2007
Completion Date:
August 2008
Related Keywords:
- Lung Cancer
- Lung Cancer
- CryoPsray Ablation
- CSA therapy
- CSA treatment
- Lobectomy
- lung resection
- Lung Neoplasms
Name | Location |
|---|---|
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
