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A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung

Phase 4
18 Years
Not Enrolling
Lung Cancer

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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:


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:


Principal Investigator

Willaim Krimsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

PCCAB, Franklin Square Hospital Center


United States: Institutional Review Board

Study ID:




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



Franklin Square Hospital CenterBaltimore, Maryland  21237