Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Targeted Lung Denervation

Group Type EXPERIMENTAL

TLD Therapy (IPS SystemTM)

Intervention Type 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.

Interventions

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TLD 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.

Intervention Type DEVICE

Other Intervention Names

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TLD Therapy, Targeted Lung Denervation Therapy

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No