COPDRECOILNCT02012673
A Safety and Feasibility Study of Re-treating Patients With Severe Emphysema With the RePneu LVRC System.
A study testing Bronchoscopic lung volume reduction in people with COPD and Emphysema, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Bronchoscopic lung volume reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Sep 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Treated with the RePneu LVRC system > 24 months ago.
- Six months after the first bilateral treatment with the RePneu LVRC system the patient had a significant improvement above the established minimal important difference (MID) of 6-minute walk distance (6MWD: 26 meter) or of forced expiratory volume in 1 second (FEV1: 100ml) or of St. Georges Respiratory Questionnaire total score (SGRQ: 4 points).
- Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
- Subject has stopped smoking for at least 6 months prior to entering the study.
- Subject read, understood and signed the Informed Consent form.
- Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
- Subject has received Influenza vaccinations consistent with local recommendations and/or policy.
Who cannot join
- Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- Subject has severe gas exchange abnormalities as defined by:
- PaCO2 >8.0 kPa; PaO2 < 6.0 kPa (room air).
- Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via echocardiogram.
- Subject has an inability to walk >140 meters in 6 minutes.
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- Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
- Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
- Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
- Subject has clinically significant bronchiectasis.
- Subject has giant bullae >1/3 lung volume.
- Subject has had previous LVR surgery, lung transplantation or lobectomy.
- Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
- Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
- Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
- Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for 7 days prior to procedure.
- Subject has a sensitivity or allergy to Nickel.
- Subject has a known sensitivity to drugs required to perform bronchoscopy.
- Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Feasibility of Re-treating Patients With Severe Emphysema With the RePneu LVRC System: a Pilot Study.
Rationale:
The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline.
Read more
Objective:
To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.
Read the detailed description
Rationale:
The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline.
Objective:
To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.
Study design:
This study is a non randomized uncontrolled intervention.
Study population: Patients with severe emphysema who have previously been treated with the lung volume reduction coil system and significantly improved in lung function, exercise capacity or quality of life, 6 months after the treatment.
Intervention:
Patients will receive a lung volume reduction coil treatment by bronchoscopy.
Main study parameter:
The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects.
Secondary study parameters:
Lung function
- Change in RV, 6 months following treatment
- Change in RV/TLC ratio, 6 months following treatment
- Changes in FEV1 and FVC, 2 and 6 months following treatment
Quality of life
- Change in the SGRQ score, 2 and 6 months following treatment
- Change in the CCQ score, 2 and 6 months following treatment
Functional measures
- Change in the mMRC score, 2 and 6 months following treatment
- Change in the 6MWD, 2 and 6 months following treatment
- Being tested
- Bronchoscopic lung volume reduction
- Keywords
- COPD, Emphysema, Bronchoscopy, Lung Volume Reduction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic lung volume reductionDevice
Bronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system. The RePneu LVRC is an implantable device, delivered through a fiber-optic bronchoscope, designed specifically to treat patients suffering from emphysema. The Coil is intended to compress the most damaged parenchyma and tension the surrounding tissue, which increases elastic recoil, reduces hyperinflation and redirects air to healthier portions of the lung for more effective ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopic lung volume reduction | Experimental | Bronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system Receives: Device: Bronchoscopic lung volume reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of adverse effects as a measure of safety between baseline and 6 months follow up
The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects.
Measured: Baseline - 6 month follow up
Secondary outcomes (6)
Change from Baseline in Lung function at 2 months
-Changes in FEV1 and FVC, 2 months following treatment
Measured: Baseline vs 2 month follow up
Change from Baseline in Quality of life at 2 months
- Change in the SGRQ score, 2 months following treatment
- Change in the CCQ score, 2 months following treatment
Measured: Baseline vs 2 month follow up
Change from Baseline in functional measures at 2 months
- Change in the mMRC score, 2 months following treatment
- Change in the 6MWD, 2 months following treatment
Measured: Baseline vs 2 month follow up
Change from Baseline in Lung function at 6 months
- Change in RV, 6 months following treatment
- Change in RV/TLC ratio, 6 months following treatment
- Changes in FEV1 and FVC, 6 months following treatment
Measured: Baseline vs 6 month follow up
Change from Baseline in quality of life at 6 months
- Change in the SGRQ score, 6 months following treatment
- Change in the CCQ score, 6 months following treatment
Measured: Baseline vs 6 month follow up
Change from Baseline in functional measures at 6 months
- Change in the mMRC score, 6 months following treatment
- Change in the 6MWD, 6 months following treatment
Measured: Baseline vs 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, University Medical Center Groningen, Department of Pulmonary Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012673
- Sponsor's protocol ID
- RECOIL-study
- Acronym
- RECOIL
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2013
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Re-treating Patients With Severe Emphysema With the RePneu LVRC System: a Pilot Study.
- ClinicalTrials.gov ID
- NCT02012673
- Acronym / sponsor ID
- RECOIL / RECOIL-study
- Keywords
- COPD, Emphysema, Bronchoscopy, Lung Volume Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Dec 2013 (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.
Rationale:
The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline.
Objective:
To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.
Detailed description
Rationale:
The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline.
Objective:
To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.
Study design:
This study is a non randomized uncontrolled intervention.
Study population: Patients with severe emphysema who have previously been treated with the lung volume reduction coil system and significantly improved in lung function, exercise capacity or quality of life, 6 months after the treatment.
Intervention:
Patients will receive a lung volume reduction coil treatment by bronchoscopy.
Main study parameter:
The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects.
Secondary study parameters:
Lung function
- Change in RV, 6 months following treatment
- Change in RV/TLC ratio, 6 months following treatment
- Changes in FEV1 and FVC, 2 and 6 months following treatment
Quality of life
- Change in the SGRQ score, 2 and 6 months following treatment
- Change in the CCQ score, 2 and 6 months following treatment
Functional measures
- Change in the mMRC score, 2 and 6 months following treatment
- Change in the 6MWD, 2 and 6 months following treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopic lung volume reduction | Experimental | Device: Bronchoscopic lung volume reductionBronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Treated with the RePneu LVRC system > 24 months ago.
- Six months after the first bilateral treatment with the RePneu LVRC system the patient had a significant improvement above the established minimal important difference (MID) of 6-minute walk distance (6MWD: 26 meter) or of forced expiratory volume in 1 second (FEV1: 100ml) or of St. Georges Respiratory Questionnaire total score (SGRQ: 4 points).
- Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
- Subject has stopped smoking for at least 6 months prior to entering the study.
- Subject read, understood and signed the Informed Consent form.
Key exclusion criteria (19 listed)
- Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- Subject has severe gas exchange abnormalities as defined by:
- PaCO2 >8.0 kPa; PaO2 < 6.0 kPa (room air).
- Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via echocardiogram.
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 |
|---|---|---|
| Bronchoscopic lung volume reductionBronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system. The RePneu LVRC is an implantable device, delivered through a fiber-optic bronchoscope, designed specifically to treat patients suffering from emphysema. The Coil is intended to compress the most damaged parenchyma and tension the surrounding tissue, which increases elastic recoil, reduces hyperinflation and redirects air to healthier portions of the lung for more effective ventilation. | Device | Bronchoscopic lung volume reduction |
Primary outcome
Number and type of adverse effects as a measure of safety between baseline and 6 months follow up
Time frame: Baseline - 6 month follow up
The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects.
6 secondary outcomes
Change from Baseline in Lung function at 2 months
Time frame: Baseline vs 2 month follow up
Change from Baseline in Quality of life at 2 months
Time frame: Baseline vs 2 month follow up
Change from Baseline in functional measures at 2 months
Time frame: Baseline vs 2 month follow up
Change from Baseline in Lung function at 6 months
Time frame: Baseline vs 6 month follow up
Change from Baseline in quality of life at 6 months
Time frame: Baseline vs 6 month follow up
Change from Baseline in functional measures at 6 months
Time frame: Baseline vs 6 month follow up
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 27 Jun 2017.
- Website of the bronchoscopic intervention center of the UMCGLink provided by the sponsor.
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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, Department of Pulmonary Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic lung volume reduction in people with COPD and Emphysema, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 inclusion and 19 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
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?
Number and type of adverse effects as a measure of safety between baseline and 6 months follow up (time frame: Baseline - 6 month follow up). 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 27 Jun 2017.