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RejuvenAir™ System Lobectomy Safety and Histology Study (Lobectomy)

Primary Purpose

Lung Neoplasms, Airway Obstruction, Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

RejuvenAir™ Radial Spray Cryotherapy

About this trial

This is an interventional device feasibility trial for Lung Neoplasms

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 60 days, for a total lobectomy or pneumonectomy procedure unrelated to this study (upper and lower lobes only).
Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 50% 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 or pneumonectomy surgical procedure.

Exclusion Criteria:

Subject is pregnant, nursing, or planning to get pregnant during study duration.
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/pneumonectomy 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 transplant.
Subject has had lung reduction surgery, including emphysema stent (s) implanted, coils or other devices for emphysema implanted.
Subject has uncontrolled coagulopathy or bleeding disorder.
Subject has participated in another clinical study within 6 weeks of baseline.
Subject has a serious medical condition, such as: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux.
Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).

Sites / Locations

Galway University Hosptial
University Medical Center Groningen
Royal Brompton Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RejuvenAir™ Radial Spray Cryotherapy

Arm Description

Subjects will receive Rejuvenair Radial SCT prior to lobectomy.

Outcomes

Primary Outcome Measures

safety

Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy or pneumonectomy surgery

Secondary Outcome Measures

Measurement of histological changes at treatment sites

Description of depth of histological treatment effect per specified treatment dose

Full Information

NCT ID

NCT02106143

First Posted

April 2, 2014

Last Updated

May 10, 2017

Sponsor

CSA Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02106143

Brief Title

RejuvenAir™ System Lobectomy Safety and Histology Study

Acronym

Lobectomy

Official Title

A Prospective Study of RejuvenAir™ System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

October 2015 (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

Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System radial spray cryotherapy is a novel procedure being developed as a treatment for conditions associated with abnormal bronchial function, such as chronic bronchitis. The development of appropriate reliable equipment, definition of therapeutic parameters, and an understanding of the tissue effects of treatment have been established through animal studies. This clinical study is being undertaken to assess the feasibility and safety of the application of a radial metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in human airways. The study design is prospective, open label, single arm multi-center study that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0 to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or pneumonectomy 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 60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to last approximately 10 months.

Detailed Description

The patient population intended to participate in this study are subjects scheduled to undergo lobectomy/pneomonectomy for peripheral lung lesions suspicious for or known to be cancer. The intention is that the spray cryotherapy dosing will be performed at the same surgical session as the intended surgery. Bronchoscopy is routinely performed just prior to the start of the lung resection and it is anticipated that the spray cryotherapy dose will be delivered at that time. Care will be taken to avoid administration of the spray cryotherapy dose at or near the surgical resection margin or near the lung lesion itself. A secondary endpoint beyond the safety and ease of delivery of the spray cryotherapy dose will be an analysis of the local tissue effect of the spray cryotherapy dose. Given that this area will reside within the anticipated resected surgical specimen, the treatment site will be inspected for evidence of depth of tissue effect using routine hematoxylin and eosin staining and light microscopy evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Airway Obstruction, Lung Cancer

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

RejuvenAir

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RejuvenAir™ Radial Spray Cryotherapy

Arm Type

Experimental

Arm Description

Subjects will receive Rejuvenair Radial SCT prior to lobectomy.

Intervention Type

Device

Intervention Name(s)

RejuvenAir™ Radial Spray Cryotherapy

Intervention Description

Metered dose radial spray cryotherapy treatment

Primary Outcome Measure Information:

Title

safety

Description

Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy or pneumonectomy surgery

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Measurement of histological changes at treatment sites

Description

Description of depth of histological treatment effect per specified treatment dose

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 60 days, for a total lobectomy or pneumonectomy procedure unrelated to this study (upper and lower lobes only). Subject has a pre-procedure post bronchodilator FEV1 of greater than or equal to 50% 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 or pneumonectomy surgical procedure. Exclusion Criteria: Subject is pregnant, nursing, or planning to get pregnant during study duration. 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/pneumonectomy 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 transplant. Subject has had lung reduction surgery, including emphysema stent (s) implanted, coils or other devices for emphysema implanted. Subject has uncontrolled coagulopathy or bleeding disorder. Subject has participated in another clinical study within 6 weeks of baseline. Subject has a serious medical condition, such as: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes, hypertension, autoimmune disease or uncontrolled gastric reflux. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Breen, MD

Organizational Affiliation

Galway University Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Pallav Shah, MD

Organizational Affiliation

Royal Brompton & Harefield NHS Foundation Trust

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dirk-Jan Slebos, MD

Organizational Affiliation

University Medical Center Geoningen

Official's Role

Study Chair

Facility Information:

Facility Name

Galway University Hosptial

City

Galway

Country

Ireland

Facility Name

University Medical Center Groningen

City

Groningen

Country

Netherlands

Facility Name

Royal Brompton Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22811511

Citation

Au JT, Carson J, Monette S, Finley DJ. Spray cryotherapy is effective for bronchoscopic, endoscopic and open ablation of thoracic tissues. Interact Cardiovasc Thorac Surg. 2012 Oct;15(4):580-4. doi: 10.1093/icvts/ivs192. Epub 2012 Jul 18.

Results Reference

background

PubMed Identifier

19664781

Citation

Krimsky WS, Broussard JN, Sarkar SA, Harley DP. Bronchoscopic spray cryotherapy: assessment of safety and depth of airway injury. J Thorac Cardiovasc Surg. 2010 Mar;139(3):781-2. doi: 10.1016/j.jtcvs.2009.03.051. Epub 2009 Aug 6. No abstract available.

Results Reference

background

PubMed Identifier

21482131

Citation

Fernando HC, Dekeratry D, Downie G, Finley D, Sullivan V, Sarkar S, Rivas R Jr, Santos RS. Feasibility of spray cryotherapy and balloon dilation for non-malignant strictures of the airway. Eur J Cardiothorac Surg. 2011 Nov;40(5):1177-80. doi: 10.1016/j.ejcts.2011.02.062. Epub 2011 Apr 8.

Results Reference

background

PubMed Identifier

22516831

Citation

Finley DJ, Dycoco J, Sarkar S, Krimsky WS, Sherwood JT, Dekeratry D, Downie G, Atwood J, Fernando HC, Rusch VW. Airway spray cryotherapy: initial outcomes from a multiinstitutional registry. Ann Thorac Surg. 2012 Jul;94(1):199-203; discussion 203-4. doi: 10.1016/j.athoracsur.2012.01.112. Epub 2012 Apr 18.

Results Reference

background

PubMed Identifier

20058314

Citation

Krimsky WS, Rodrigues MP, Malayaman N, Sarkar S. Spray cryotherapy for the treatment of glottic and subglottic stenosis. Laryngoscope. 2010 Mar;120(3):473-7. doi: 10.1002/lary.20794.

Results Reference

background

PubMed Identifier

23825781

Citation

Browning R, Parrish S, Sarkar S, Turner JF Jr. First report of a novel liquid nitrogen adjustable flow spray cryotherapy (SCT) device in the bronchoscopic treatment of disease of the central tracheo-bronchial airways. J Thorac Dis. 2013 Jun;5(3):E103-6. doi: 10.3978/j.issn.2072-1439.2013.05.26. No abstract available.

Results Reference

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RejuvenAir™ System Lobectomy Safety and Histology Study

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