A Non-randomized Study to Evaluate the Safety and Performance of the Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung

A Non-randomized Study to Evaluate the Safety and Performance of the Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung - Portaero trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34355

Enrollment

Registered

2010-08-27

Start date

2010-11-04

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

COPD Emphysema

Interventions

Pneumostoma Surgical Technique The Portaero Access Tube is placed either percutaneously or through a small incision, 4-8 cm in length, on the chest wall of the target lung. In both insertion techniq

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - HRCT consistent with severe emphysema grade >2/4 - FEV1 150% predicted, TLC > 100% predicted - Arterial Bloodgas PaO2 > 45 mmHg and PaCO 20 pack years

Exclusion criteria

Exclusion criteria: - History of recurrent respiratory infections - Cardiovasculair pathology - Inability to walk > 140 meters in 6 minutes - Giant bullae (> 1/3 lung volume) - Patient is taking > 10 mg prednisone (or similar steroid) daily - Patient has evidence of other disease that may compromise survival (such as lung cancer)

Design outcomes

Primary

Measure	Time frame
Study Outcomes * Safety The safety assessments include the incidence of complications and adverse events. * Performance Primary: Improvement is shown at 6 months when at least one of the following is achieved: * change in FEV1 of greater than or equal to 12% (FEV1 >=12%) from baseline; * decrease in SGRQ (Total) of 4 points or more from baseline.	—

Secondary

Measure	Time frame
Changes in FVC, RV, RV/TLC, lung volume CT Scan, 6MWT, cycle ergometry, mMRC dyspnea score, and EQ-5D.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)