RejuvenAir Lobectomy for Safety and Histology

NCT ID: NCT02483052

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-02-29

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.

Conditions

Lung Neoplasms; Pulmonary Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RejuvenAir

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.

Group Type: EXPERIMENTAL

RejuvenAir

Intervention Type: DEVICE

RejuvenAir

Interventions

RejuvenAir

RejuvenAir

Intervention Type: DEVICE

Other Intervention Names

RejuvenAir™ System Radial Spray Cryotherapy

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSA Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kashif Irshad, MDCM, MSc

Role: PRINCIPAL_INVESTIGATOR

WIlliam Osler Health Systems

Locations

William Osler Health System

Brampton, Ontario, Canada

Countries

Canada

Other Identifiers

013

Identifier Type: -

Identifier Source: org_study_id