Clinical trial NCT01716598: Evaluation of the IPS System for TLD Therapy in Patients With COPD
Official title: IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
TLD Therapy
Targeted Lung Denervation Therapy
IPS
Innovative Pulmonary Solutions, Inc.
Holaira, Inc.
Lead sponsor: Nuvaira, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.

Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.


Eligibility criteria: Inclusion Criteria:

* FEV1 30% to 60%
* Patient is diagnosed with COPD
* Positive relative change in FEV1 of greater than 15%
* Patient 40 years of age or older at the time of consent
* Smoking history of at least 10 pack years
* Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

* Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
* Documented history or current evidence of congestive heart failure
* Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
* Patient has a PaCO2 \> 8.0 kPa (60 mm Hg)
* Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
* Pulmonary nodule requiring surgery
* History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
* Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 365 Days
Secondary outcomes:
measure: Performance
timeFrame: 365 days
Other outcomes:
Locations:
city: Sanatoriumstrasse 2
country: Austria
facility: Otto-Wagner Hospital and Medical Center
state: Vienna
city: Grenoble
country: France
facility: Centre Hospitalier et Universitaire de Grenoble
city: Reims
country: France
facility: Centre Hospitalier University de Reims
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
Study officials:
affiliation: Otto-Wagner Hospital, Vienna, Austria
name: Arschang Valipour, MD, FCCP, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: