RejuvenAir™ System Lobectomy Safety and Histology Study

NCT02106143 | Completed DMC

• 1 other identifier: 009
• Study Type: interventional
• Target: 11
• Locations: 3 countries
• Sites: 3

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.

Conditions

Lung Neoplasms; Airway Obstruction; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  2 months

Secondary Outcomes (1)

• Measurement of histological changes at treatment sites

  2 months

Study Arms (1)

RejuvenAir™ Radial Spray Cryotherapy

EXPERIMENTAL

Subjects will receive Rejuvenair Radial SCT prior to lobectomy.

Device: RejuvenAir™ Radial Spray Cryotherapy

Interventions

RejuvenAir™ Radial Spray Cryotherapy DEVICE

Metered dose radial spray cryotherapy treatment

RejuvenAir™ Radial Spray Cryotherapy

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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CSA Medical, Inc.: lead

Study Sites (3)

Galway University Hosptial

Galway, Galway, Ireland

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 22811511 BACKGROUND

• 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.

  PMID: 19664781 BACKGROUND

• 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.

  PMID: 21482131 BACKGROUND

• 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.

  PMID: 22516831 BACKGROUND

• 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.

  PMID: 20058314 BACKGROUND

• 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.

  PMID: 23825781 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiratory Insufficiency; Respiration Disorders

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RejuvenAir

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 8, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IE (1); GB (1)