Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Medical Center Groningen (UMCG), Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

FEV1 30% to 60%
FEV1/FVC <70%
Prior smoker (at least 10 pack years)
Quit smoking for at least 6 months

Exclusion criteria

Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
Pulmonary nodule requiring surgery
Presence of implantable electronic devices
Active respiratory infection within recent weeks
COPD exacerbation within recent weeks
Recent Myocardial infarction (MI)
Recent and unstable or life threatening arrhythmia
Malignancy treated with radiation or chemotherapy within the last 2 years
Presence or clinical diagnosis of other respiratory diseases other than COPD

Treatment and study plan

TLD Therapy (IPS SystemTM)

Device

Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.

Other names: TLD Therapy, Targeted Lung Denervation Therapy

Primary outcomes

Primary Safety Endpoint

Time frame: 365 days post procedure

Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.

Secondary outcomes

Technical Feasibility

Time frame: At time of Treatment

The ability to access the target treatment area and deliver RF energy to the target treatment site.

Sponsors and collaborators

Lead sponsor

Nuvaira, Inc.

Industry

Registry information

Official study title

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

Acronym: IPS-I

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2015
First posted: Dec 1, 2011
Registry last updated: Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed