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

Phase 1

Suspended

• Conditions: Severe Emphysema; Respiratory - Chronic obstructive pulmonary disease; Hyperinflation of the lung

• Registration Number: ACTRN12616000972426
• Lead Sponsor: Soffio Medical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety will be determined by the incidence of any serious adverse events reported either by the patient or observed by the investigator, relating to the procedure or to the device itself either perioperatively or in the follow-up period as determined by the Independent Medical Monitor. Adverse events that will be assessed may include (but not be limited to) exacerbations of COPD, device related events including pneumothorax and surgical emphysema (leakage of air into the chest cavity or under the skin) , bleeding from the chest wall or lung around the implant insertion site. These events will be assessed by clinical examination and may also include tests such as X-rays, CT scans and routine blood tests. All adverse events will be documented. [12 months from insertion of the ARIA ETS device.]

Secondary Outcome Measures

Name	Time	Method
Effectiveness outcomes to be evaluated in this study are:<br>Technical success. This will be assessed by successful placement of the device and the detection of airflow through the device<br>[Upon insertion of device and prior to hospital disccharge];Lung and Lobar Volumes assessed by CT Scan[6 months from insertion of device];Pulmonary function test results as assessed by the performance of spirometry testing[3, 6 and 12 months from insertion of device];Exercise tolerance as measured by 6 minute walk test and cycle ergometry.[3, 6 and 12 months from insertion of device.];Health Indices Assessment as assessed by the completion of questionnaires such as SGRQ and EQ-5D.[3, 6 and 12 months from insertion of device.];Symptoms assessed using the modified Medical Research Council (mMRC) dyspnea survey and COPD Assessment Test Score (CATS)[3, 6 and 12 months from insertion of device.]