RejuvenAir Lobectomy for Safety and Histology

NCT02483052 | Completed Phase 1 DMC

• 1 other identifier: 013
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Pulmonary Neoplasms

Keywords

lobectomy; spray cryotherapy; lung cancer

Outcome Measures

Primary Outcomes (1)

• Safety measured by occurrence of serious adverse events related to metered dose radial spray cryothreapy

  prior to lobectomy-up to 14 days

Secondary Outcomes (1)

• Histology assessed by description of depth of histological treatment effect per specified treatment dose

  up to 90 days

Study Arms (1)

RejuvenAir

EXPERIMENTAL

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.

Device: RejuvenAir

Interventions

RejuvenAir DEVICE

RejuvenAir

Also known as: RejuvenAir™ System Radial Spray Cryotherapy

RejuvenAir

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (1)

William Osler Health System

Brampton, Ontario, L6R 3J7, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kashif Irshad, MDCM, MSc

  WIlliam Osler Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RejuvenAir

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)