Skip to main content
OpenTrials
Completed

NCT Number: NCT00747773

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CryoSpray Ablation System

Device

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

Primary outcomes

  1. The primary safety endpoint for this study is patient safety

    Time frame: Throughout study

  2. The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients

    Time frame: Throughout Study

Sponsors and collaborators

Lead sponsor

CSA Medical, Inc.

Industry

Registry information

Official study title

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

Acronym: CSAir 1

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 5, 2008
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.