Cryospray Ablation of Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung (CSAir 1)

CSA Medical

Status and phase: Completed; Phase 4

Conditions: Lung Cancer

Treatments: Device: CryoSpray Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747773

17-00008-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)