Chronic Obstructive Pulmonary Disease (COPD)Phase 1IPS-INCT01483534
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
A Phase 1 study testing TLD Therapy (IPS SystemTM) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nuvaira, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy. 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?
- TLD Therapy (IPS SystemTM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2011to Nov 2015
- 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%
- FEV1/FVC <70%
- Prior smoker (at least 10 pack years)
- Quit smoking for at least 6 months
Who cannot join
- Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
- Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
- Pulmonary nodule requiring surgery
- Presence of implantable electronic devices
- Active respiratory infection within recent weeks
- COPD exacerbation within recent weeks
Show all 10Show fewer
- Recent Myocardial infarction (MI)
- Recent and unstable or life threatening arrhythmia
- Malignancy treated with radiation or chemotherapy within the last 2 years
- Presence or clinical diagnosis of other respiratory diseases other than COPD
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
Stellenbosch University
Capetown, 7505
Panorama Medi-Clinic
Panorama, Cape Town
Netherlands1 site
University Medical Center Groningen (UMCG)
Groningen, 9700
About this study
Official title: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.
- Being tested
- TLD Therapy (IPS SystemTM)
- Keywords
- Chronic Obstructive Pulmonary Disease, Pulmonary, Intervention, Device, Denervation, Lung, Holaira, Inc., Innovative Pulmonary Solutions, 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.
TLD Therapy (IPS SystemTM)Device
Also called TLD Therapy, Targeted Lung Denervation Therapy
Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Lung Denervation | Experimental | Targeted Lung Denervation Receives: Device: TLD Therapy (IPS SystemTM) |
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 post procedure
Secondary outcomes (1)
Technical Feasibility
The ability to access the target treatment area and deliver RF energy to the target treatment site.
Measured: At time of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvaira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirk-Jan Slebos, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483534
- Sponsor's protocol ID
- CLP-001
- Acronym
- IPS-I
- Status last verified
- Feb 2016
- First submitted
- 29 Nov 2011
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4.
PubMed 25739911
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
- Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study
- ClinicalTrials.gov ID
- NCT01483534
- Acronym / sponsor ID
- IPS-I / CLP-001
- Keywords
- Chronic Obstructive Pulmonary Disease, Pulmonary, Intervention, Device, Denervation, Lung, Holaira, Inc., Innovative Pulmonary Solutions, Inc.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nuvaira, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Dec 2011 (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.
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Lung Denervation | Experimental | Device: TLD Therapy (IPS SystemTM)Targeted Lung Denervation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FEV1 30% to 60%
- FEV1/FVC <70%
- Prior smoker (at least 10 pack years)
- Quit smoking for at least 6 months
Key exclusion criteria (10 listed)
- Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
- Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
- Pulmonary nodule requiring surgery
- Presence of implantable electronic devices
- Active respiratory infection within recent weeks
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 |
|---|---|---|
| TLD Therapy (IPS SystemTM)Also: TLD Therapy, Targeted Lung Denervation TherapyTargeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment. | Device | Targeted Lung Denervation |
Primary outcome
Primary Safety Endpoint
Time frame: 365 days post procedure
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
1 secondary outcome
Technical Feasibility
Time frame: At time of Treatment
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.
- Results publication: PubMed 25739911Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4.
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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.
Dirk-Jan Slebos, MD, PhD principal investigator
University Medical Center Groningen
3 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 TLD Therapy (IPS SystemTM) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nuvaira, Inc. at 3 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 4 inclusion and 10 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 3 sites in South Africa, Netherlands. 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 post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01483534, which also lists 1 linked publication.
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.