Chronic Obstructive Pulmonary Disease (COPD)Phase 1IPS-IINCT01716598
Evaluation of the IPS System for TLD Therapy in Patients With COPD
A Phase 1 study testing IPS System in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nuvaira, Inc. at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- IPS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2012to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Centre Hospitalier et Universitaire de Grenoble
Grenoble
Centre Hospitalier University de Reims
Reims
Nouvel Hopital Civil
Strasbourg
Austria1 site
Otto-Wagner Hospital and Medical Center
Sanatoriumstrasse 2, State of Vienna, 1140
About this study
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.
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.
- Being tested
- IPS System
- Keywords
- COPD, TLD Therapy, Targeted Lung Denervation Therapy, IPS, Innovative Pulmonary Solutions, Inc., Holaira, Inc.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS SystemDevice
Also called TLD Therapy, Targeted Lung Denervation Therapy
TLD Therapy will be achieved bronchoscopically.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Targeted Lung Denervation Therapy (TLD Therapy) Receives: Device: IPS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
Measured: 365 Days
Secondary outcomes (1)
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.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvaira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arschang Valipour, MD, FCCP, Ass. Prof., Principal investigator, Otto-Wagner Hospital, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716598
- Sponsor's protocol ID
- CLP-002
- Other IDs
- CVI-12-03-005102
- Acronym
- IPS-II
- Status last verified
- Sep 2016
- First submitted
- 4 Oct 2012
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01716598
- Acronym / sponsor ID
- IPS-II / CLP-002
- Keywords
- COPD, TLD Therapy, Targeted Lung Denervation Therapy, IPS, Innovative Pulmonary Solutions, Inc., Holaira, Inc.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nuvaira, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: IPS SystemTargeted Lung Denervation Therapy (TLD Therapy) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPS SystemAlso: TLD Therapy, Targeted Lung Denervation TherapyTLD Therapy will be achieved bronchoscopically. | Device | Treatment |
Primary outcome
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.
1 secondary outcome
Performance
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arschang Valipour, MD, FCCP, Ass. Prof. principal investigator
Otto-Wagner Hospital, Vienna, Austria
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPS System in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nuvaira, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 365 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.