NCT01716598

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2012

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

October 4, 2012

Last Update Submit

September 22, 2016

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDTLD TherapyTargeted Lung Denervation TherapyIPSInnovative Pulmonary Solutions, Inc.Holaira, Inc.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Performance

    365 days

Study Arms (1)

Treatment

EXPERIMENTAL

Targeted Lung Denervation Therapy (TLD Therapy)

Device: IPS System

Interventions

IPS SystemDEVICE

TLD Therapy will be achieved bronchoscopically.

Also known as: TLD Therapy, Targeted Lung Denervation Therapy
Treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Otto-Wagner Hospital and Medical Center

Sanatoriumstrasse 2, Vienna, 1140, Austria

Location

Centre Hospitalier et Universitaire de Grenoble

Grenoble, France

Location

Centre Hospitalier University de Reims

Reims, France

Location

Nouvel Hopital Civil

Strasbourg, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arschang Valipour, MD, FCCP, Ass. Prof.

    Otto-Wagner Hospital, Vienna, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 30, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

April 1, 2016

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

AU(1)FR(3)