Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01483534

Acronym

IPS-I

Enrollment

Registered

2011-12-01

Start date

2011-10-31

Completion date

2015-11-30

Last updated

2016-09-23

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease, Pulmonary, Intervention, Device, Denervation, Lung, Holaira, Inc., Innovative Pulmonary Solutions, Inc.

Brief summary

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.

Interventions

DEVICETLD Therapy (IPS SystemTM)

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Safety Endpoint	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

Measure	Time frame	Description
Technical Feasibility	At time of Treatment	The ability to access the target treatment area and deliver RF energy to the target treatment site.

Countries

Netherlands, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026