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Trial record 1 of 1 for:    NCT02106143
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RejuvenAir™ System Lobectomy Safety and Histology Study (Lobectomy)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02106143
First Posted: April 8, 2014
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CSA Medical, Inc.
  Purpose
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.

Condition Intervention
Lung Neoplasms Airway Obstruction Lung Cancer Device: RejuvenAir™ Radial Spray Cryotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
RejuvenAir
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Prospective Study of RejuvenAir™ System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung

Resource links provided by NLM:


Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • safety [ Time Frame: 2 months ]
    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 [ Time Frame: 2 months ]
    Description of depth of histological treatment effect per specified treatment dose


Enrollment: 11
Study Start Date: September 2014
Study Completion Date: October 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RejuvenAir™ Radial Spray Cryotherapy
Subjects will receive Rejuvenair Radial SCT prior to lobectomy.
Device: RejuvenAir™ Radial Spray Cryotherapy
Metered dose radial spray cryotherapy treatment

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106143


Locations
Ireland
Galway University Hosptial
Galway, Ireland
Netherlands
University Medical Center Groningen
Groningen, Netherlands
United Kingdom
Royal Brompton Hospital
London, United Kingdom
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Study Chair: David Breen, MD Galway University Hospital
Study Chair: Pallav Shah, MD Royal Brompton & Harefield NHS Foundation Trust
Study Chair: Dirk-Jan Slebos, MD University Medical Center Geoningen
  More Information

Publications:

Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT02106143     History of Changes
Other Study ID Numbers: 009
First Submitted: April 2, 2014
First Posted: April 8, 2014
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Neoplasms
Airway Obstruction
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders