Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)

• ClinicalTrials.gov Identifier: NCT01716598
• Recruitment Status: Completed
• First Posted: October 30, 2012
• Last Update Posted: September 23, 2016
• Sponsor: Nuvaira, Inc.
• Information provided by (Responsible Party): Nuvaira, Inc.

Tracking Information

• First Submitted Date: October 4, 2012
• First Posted Date: October 30, 2012
• Last Update Posted Date: September 23, 2016
• Study Start Date: October 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 21, 2013)

Primary Safety Endpoint [ Time Frame: 365 Days ]

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

Original Primary Outcome Measures (submitted: October 25, 2012)

• Primary [ Time Frame: 180 days ]
  Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
• Primary [ Time Frame: Acute ]
  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 as confirmed by the IPS Console at the time of the procedure.

Current Secondary Outcome Measures (submitted: May 21, 2013)

Performance [ Time Frame: 365 days ]

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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Device: IPS System

TLD Therapy will be achieved bronchoscopically.

Other Names:

• TLD Therapy
• Targeted Lung Denervation Therapy

Study Arms

Experimental: Treatment

Targeted Lung Denervation Therapy (TLD Therapy)

Intervention: Device: IPS System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 21, 2013): 15
• Original Estimated Enrollment (submitted: October 25, 2012): 35
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, France

Administrative Information

• NCT Number: NCT01716598
• Other Study ID Numbers: CLP-002; CVI-12-03-005102 ( Other Identifier: Eudamed Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nuvaira, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Nuvaira, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Arschang Valipour, MD, FCCP, Ass. Prof.; Otto-Wagner Hospital, Vienna, Austria

• PRS Account: Nuvaira, Inc.
• Verification Date: September 2016