Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung

Completed · Phase 4

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00747773

Run by

CSA Medical, Inc.

People needed

21

Starts

2007-11-01

Expected to finish

2008-08-01

Last updated by the study team

2014-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years of age
• Lobectomy planned based on clinical situation not related to this study.
• Deemed operable based on institutional criteria.

You may not qualify if…

• 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

Where it is running

• Franklin Square Hospital Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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