RejuvenAir Lobectomy for Safety and Histology (LobectomyCAN)
Primary Purpose
Lung Neoplasms, Pulmonary Neoplasms
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
RejuvenAir
Sponsored by
About this trial
This is an interventional other trial for Lung Neoplasms focused on measuring lobectomy, spray cryotherapy, lung cancer
Eligibility Criteria
Inclusion Criteria:
Males and females of 21 to 75 years of age.
- Subject is able to read, understand, and sign a written Informed Consent to participate in the study.
- Subject is scheduled within 90 days from date of study treatment for a lobectomy unrelated to this study (upper and lower lobes only). Preferred range is 2-14 days from study treatment.
- Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 40% of predicted.
- Subject is able to undergo bronchoscopy in the opinion of the investigator or per hospital guidelines.
- Subject is able to adhere to and undergo a scheduled bronchoscope procedure prior to their clinically scheduled lobectomy surgical procedure.
Exclusion Criteria:
• Subject is pregnant, nursing, or planning to get pregnant during study duration.
- Subject is scheduled to have a pneumonectomy or has had a previous contralateral pneumonectomy.
- Subject has had prior radiation therapy which involved the lungs.
- Subject has received chemotherapy within the past 6 months, or is anticipated to be treated with chemotherapy between initial study treatment and lobectomy procedure.
- Subject has an acute pulmonary infection or pneumonia within 6 weeks prior to study bronchoscopy.
- Subject has had COPD exacerbation within 6 weeks prior to study bronchoscopy.
- Subject has bronchiectasis in the area to be treated.
- Subject has bullous emphysema. Characterized as large bullae >3 centimeters and confirmed on CT.
- Subject has had a Lung transplant.
- Subject has had lung reduction surgery, including implanted emphysema stent (s) implanted, coils or other devices for treatment.
Sites / Locations
- William Osler Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RejuvenAir
Arm Description
RejuvenAir if the treatment areas are designated as Segmental, males will be dosed for 11 seconds and females for 10 seconds. If dosing is in the Lobar area males will be dosed for 12 seconds and females for 11 seconds.
Outcomes
Primary Outcome Measures
Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy
Secondary Outcome Measures
Histology assessed by description of depth of histological treatment effect per specified treatment dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02483052
Brief Title
RejuvenAir Lobectomy for Safety and Histology
Acronym
LobectomyCAN
Official Title
A Prospective Study of RejuvenAir System Radial Spray Cryotherapy to Determine Safety and Delayed Histological Effect in the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSA Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RejuvenAir System treatment will be performed during preoperative bronchoscopy 2 to 90 days prior to prescheduled lung resection in Subjects requiring lobectomy for removal of peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that will be removed, distal to the anticipated margin of resection. Treatment should be at least 1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and examined histologically following surgical resection. Subject participation will be from 1 to 90 days and enrollment is anticipated to take 3 months. Subject having a RejuvenAir procedure and not going on to a resection for any reason will be followed for a maximum of 90 days for safety and undergo bronchoscopic evaluation of the treated airways at 90 days (+/- 4 Days)) post treatment.
Detailed Description
The study is a prospective, open label, single arm, single center study. The objective is to study the safety of the RejuvenAir System in a population of subjects who are scheduled to undergo a planned lobectomy. A secondary objective is to determine the histological effects of RejuvenAir System treatment in the airways. The Primary Endpoint is Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy surgery. The patient population intended to participate in this study are subjects scheduled to undergo lobectomy for peripheral lung lesions suspicious for or known to be cancer. Secondarily, this will enable an understanding of the histological characteristics and healing outcomes post-treatment in the airways, which will be resected. CSA Medical has conducted bench and animal studies that support the use of the RejuvenAir System as sufficiently safe and effective to warrant advancing the product into this primary safety study in patients presenting for consideration of lobectomy. Such patients provide a safe population to further the clinical evaluation of the system in that these subjects will receive their lobectomy or procedure 2 to 14 days following delivery of their metered liquid nitrogen treatment. At the time of their metered liquid nitrogen treatment they will be in an operating room setting with their thoracic surgeon in attendance. It is anticipated that subjects who agree to participate in this study will have the metered liquid nitrogen treatment at the time of evaluation of their lung lesion. This evaluation will include bronchoscopy with ultrasound for evaluation of their lymph nodes prior to the planned surgical resection of their lung abnormality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Pulmonary Neoplasms
Keywords
lobectomy, spray cryotherapy, lung cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
RejuvenAir
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RejuvenAir
Arm Type
Experimental
Arm Description
RejuvenAir if the treatment areas are designated as Segmental, males will be dosed for 11 seconds and females for 10 seconds. If dosing is in the Lobar area males will be dosed for 12 seconds and females for 11 seconds.
Intervention Type
Device
Intervention Name(s)
RejuvenAir
Other Intervention Name(s)
RejuvenAir™ System Radial Spray Cryotherapy
Intervention Description
RejuvenAir
Primary Outcome Measure Information:
Title
Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy
Time Frame
prior to lobectomy-up to 14 days
Secondary Outcome Measure Information:
Title
Histology assessed by description of depth of histological treatment effect per specified treatment dose
Time Frame
up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females of 21 to 75 years of age.
Subject is able to read, understand, and sign a written Informed Consent to participate in the study.
Subject is scheduled within 90 days from date of study treatment for a lobectomy unrelated to this study (upper and lower lobes only). Preferred range is 2-14 days from study treatment.
Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 40% of predicted.
Subject is able to undergo bronchoscopy in the opinion of the investigator or per hospital guidelines.
Subject is able to adhere to and undergo a scheduled bronchoscope procedure prior to their clinically scheduled lobectomy surgical procedure.
Exclusion Criteria:
• Subject is pregnant, nursing, or planning to get pregnant during study duration.
Subject is scheduled to have a pneumonectomy or has had a previous contralateral pneumonectomy.
Subject has had prior radiation therapy which involved the lungs.
Subject has received chemotherapy within the past 6 months, or is anticipated to be treated with chemotherapy between initial study treatment and lobectomy procedure.
Subject has an acute pulmonary infection or pneumonia within 6 weeks prior to study bronchoscopy.
Subject has had COPD exacerbation within 6 weeks prior to study bronchoscopy.
Subject has bronchiectasis in the area to be treated.
Subject has bullous emphysema. Characterized as large bullae >3 centimeters and confirmed on CT.
Subject has had a Lung transplant.
Subject has had lung reduction surgery, including implanted emphysema stent (s) implanted, coils or other devices for treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kashif Irshad, MDCM, MSc
Organizational Affiliation
WIlliam Osler Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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RejuvenAir Lobectomy for Safety and Histology
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