Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study

Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study - Targeted Lung Denervation in COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39206

Enrollment

Registered

2011-08-25

Start date

2011-11-16

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

chronic bronchitis COPD

Interventions

Bronchoscopically guided Targeted Lung Denervation (TLD) Therapy with the Innovative Pulmonary Solutions (IPS) System.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: FEV1 30% - 60% of predicted FEV1/FVC

Exclusion criteria

Exclusion criteria: Asthma Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy Presence of a pacemaker, internal defibrillator or other implantable electronic devices

Design outcomes

Primary

Measure	Time frame
Primary Safety Endpoint: Freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure to 180-days post TLD Therapy.	—

Secondary

Measure	Time frame
Technical Feasibility (performance) Endpoint: The ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site as confirmed by the IPS Console.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)