The primary objective of the study is to prospectively confirm the safety and effectiveness profile of Coil treatment in consideration of the findings of previous Randomized Controlled Trials.Secondary objectives are determination of responder rates…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: number and kind of (serious) adverse events
Co-Primary Effectiveness Endpoints:
* Percent change in FEV1 from baseline to 6 months and
* Change in SGRQ from baseline to 6 months
Secondary outcome
Secondary Effectiveness Endpoints:
** Responder rate at 6 months defined as percent of subjects that achieve two
or more of the following MCIDs;
Change from baseline in:
6MWT * 26 meters, SGRQ * -4 points, FEV1 * 10%, Decrease in RV < 350 ml
* *Change in Mean Expiratory Lobar Volume (LoVRexp) of the treated lobes from
Baseline to 6 months
* *Change in Vital Capacity (VC) as measured by plethysmography from Baseline
to 6 months
Other Effectiveness Endpoints:
** Changes in other Pulmonary Function measures (RV, RV/TLC, FEV1, FEV1/FVC)
* *Change in Exercise Capacity (6MWT)
* *Change at 6 months for CAT and EQ5D
* *Individual MCID responder rates at 6 months for 6MWT, SGRQ, and FEV1 as
defined above
* *Responder rate at 6 months defined as percent of subjects that achieve FEV1
* 12%
* *Responder rate at 6 months defined as percent of subjects that achieve SGRQ
* -8 points
Background summary
The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a
bronchoscopic lung volume reduction treatment designed to compress the areas of
lung parenchyma most damaged by emphysema. The LVRC treatment was found to be
feasible, safe and effective in previous studies. Another aspect of the
treatment which we to date do not fully understand is which group of patients
benefit of the treatment and which group of patients do not, this knowing that
the responder rate is already about 60%. The RENEW trial, a multicenter RCT
identified various subgroups of patients with a better clinical response after
the coil treatment. This trial will investigate the safety and efficacy of the
coil treatment in this group op best responders to hopefully gain more insight
on the best-responder profile of the treatment.
Study objective
The primary objective of the study is to prospectively confirm the safety and
effectiveness profile of Coil treatment in consideration of the findings of
previous Randomized Controlled Trials.
Secondary objectives are determination of responder rates to clinical endpoints
and mean change in physiologic endpoints.
Study design
Prospective, multicenter, open label, randomized (2:1), controlled study
comparing outcomes in subjects treated with the PneumRx Endobronchial Coil
System (Coil) to a medically-managed control group. The medically-managed
control group will be eligible to crossover after 6 months.
Intervention
The Coil System is a CE-Marked implantable device that is indicated for use in
patients with homogeneous and/or heterogeneous severe emphysema to improve
quality of life, lung function, and exercise capacity.
The Coil System consists of sterile Endobronchial Coils which come in 3
different sizes (100 mm, 125 mm, and 150mm) and a sterile, disposable,
single-procedure Delivery System consisting of a Cartridge, Catheter, Guidewire
and Forceps.
The Coil System is designed for bilateral treatment using a therapeutic
bronchoscope with a 2.8 mm working channel and fluoroscopy for visualization
beyond the bronchoscope.
Study burden and risks
The LVR Coil has been designed to be as safe as possible. It was shown that the
risks associated with the LVRC system are largely attributable to the
bronchoscopic procedure itself rather than to the device per se. Therefore, it
appears that the LVRC device itself does not appreciably increase the risk of
serious adverse events beyond the risk of undergoing a bronchoscopy procedure
or simply having emphysema. Currently, this treatment is not commercially
available in the Netherlands and study participants will have to visit the
hospital multiple times. Previous studies have shown that the treatment has
beneficial effect for the patient, however not all patients respond. Therefore,
it is possible that a patient will not receive any benefits from the
treatment.
Burton Drive 4255
Santa Clara 95054 CA
US
Burton Drive 4255
Santa Clara 95054 CA
US
Listed location countries
Age
Inclusion criteria
1. Read, understood and signed the Informed Consent form
2. Meets indications for use per the IFU
3. Bilateral heterogeneous and/or homogeneous emphysema
4. 15% predicted * Post bronchodilator Forced Expiratory Volume in 1 second (FEV1) * 45% predicted
5. Post bronchodilator Residual Volume (RV) * 200% predicted
6. Post bronchodilator Total Lung Capacity (TLC) >100% predicted
7. Post bronchodilator RV/TLC > 55%
8. Dyspnea * 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
9. Receiving optimal drug therapy and medical management according to clinical practice.
10. Performing regular physical activity, at least 2 times per week 3
11. Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
12. 100m * 6 minute walk distance (6MWD) * 450m
13. Deemed eligible per Eligibility Review Committee (ERC)
Exclusion criteria
1. Meets any of the contraindications listed in the IFU
2. Primary diagnosis of asthma
3. Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations4.
4. Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
5. Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
6. Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease (predominant bulla > 8cm or 1/3 hemithorax), or severe bullous or predominant paraseptal emphysema pattern
7. Lung pathology of nodule not proven stable or benign
8. Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant 9. Use of more than 10 mg/day prednisolone or equivalent dosage of a different corticosteroid
10. Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
11. Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
12. Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
13. Diagnosed with alpha-1 antitrypsin deficiency
14. DLCO < 20 %
15. Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
16. Body Mass Index (BMI) > 30.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03360396 |
| CCMO | NL64150.042.18 |