SuspendedPhase 1ACTRN12616000972426

ARIA ETS (Emphysema Treatment System) Clinical Trial for patients with Severe Emphysema

A Non-Randomized Study to Evaluate the Safety and Performance of the ARIA Trademark Emphysema Treatment System in Patients with Severe Emphysema with Hyperinflation of the Lung


Sponsor

Soffio Medical Inc.

Enrollment

30 participants

Start Date

Sep 28, 2016

Study Type

Interventional

Conditions

Summary

An non-randomised (single group) trial to test the safety and efficacy of the ARIA Emphysema Treatment System (ETS) for patients with Severe Emphysema and Hyperinflation of the Lung. The ETS device will be implanted in the lung and will remain insitu for the duration of the clinical trial.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Inclusion Criteria4

  • Severe emphysema with hyperinflation of the lung
  • Candidate for general anaesthesia
  • FEV1 > 18% and < 45%
  • BMI < 31.1 (Men) and <32.3 (Women)

Exclusion Criteria5

  • Sensitivity to Nitinol
  • Patient is on Lung Transplant Waiting List
  • Alpha 1 Antitrypsin deficiency
  • Significant bleeding risk
  • Known lung cancer or pulmonary nodules that require investigation

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Insertion of the ARIA Emphysema Treatment System (ETS) will occur during an approximate 60 minute thoracic surgery procedure. The ARIA ETS, which is a device that is secured in the lung and vents via

Insertion of the ARIA Emphysema Treatment System (ETS) will occur during an approximate 60 minute thoracic surgery procedure. The ARIA ETS, which is a device that is secured in the lung and vents via a tube to the outside of the chest will remain implanted in the patient's chest for the duration of the trial (12months from implantation of device). The premise of the technology is that it reduces hyperinflation of the lung which leads to emphysematous symptoms. Implantation of the device, ongoing assessment and follow up will be performed in an accredited hospital providing tertiary thoracic surgery and respiratory medicine services. Tests required to participate in the study will include CT Scan, Respiratory Function Testing, Exercise Testing (Cycle and 6 Minute Walk Test), Blood tests and intermittent bronchoscopies via the ARIA ETS system.


Locations(3)

The Alfred - Prahran

WA,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

WA,VIC, Australia

Germany

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616000972426


Related Trials