Evaluation of the IPS System for TLD Therapy in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— IPS-II  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716598
• Other study ID #: CLP-002
• Secondary ID: CVI-12-03-005102
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2012
• Last updated: September 22, 2016
• Start date: October 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Holaira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateFrance: Agence Nationale de Sécurité du Médicament et des produits de santéAustria: Austrian Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• IPS System
TLD Therapy will be achieved bronchoscopically.

Locations

Country	Name	City	State
Austria	Otto-Wagner Hospital and Medical Center	Sanatoriumstrasse 2	Vienna
France	Centre Hospitalier et Universitaire de Grenoble	Grenoble
France	Centre Hospitalier University de Reims	Reims
France	Nouvel Hopital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Holaira

Countries where clinical trial is conducted

Austria,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.	365 Days	Yes
Secondary	Performance	Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation.	365 days	No