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

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000972426

Acronym

ARIA ETS

Enrollment

Registered

2016-07-25

Start date

2016-09-28

Completion date

2016-11-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results