A Study Of Cryospray Ablationtm Using Surgical Resection Specimens To Determine Safety And Histological Effect In The Lung
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- CSA Medical, Inc.
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- The primary safety endpoint for this study is patient safety
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The primary safety endpoint for this study is patient safety
Time Frame: Throughout study
The primary efficay endpoint is histological effects of cryospray therapy in lobectomy patients
Time Frame: Throughout Study
Secondary Outcomes
No secondary outcomes reported