EmphysemaNCT02499380
Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment
An observational study of Emphysema, run by Boston Scientific Corporation at 2 sites in Germany.
Trial summary
The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- PneumRx Coil System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Jun 2015to 20 Oct 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects diagnosed with emphysematous type of COPD
Who may be able to join
- Adult subjects diagnosed with emphysematous type of COPD.
- CT scan indicates bilateral emphysema, with sufficient lung parenchyma for coil deployment (based on PneumRx CT scoring) criteria.
- Subject has post-bronchodilator FEV1 ≤45% predicted.
- Subject has Total Lung Capacity >100% predicted.
- Subject has residual volume (RV) ≥175% predicted.
- Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
- Subject read, understood and signed the Informed Consent form.
- Subject has received Pneumococcal and 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 not due to dyspnea.
- Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
- Subject has severe gas exchange abnormalities as defined by:
- PaCO2 >55 mm Hg
- PaO2 <45 mm Hg on room air (High altitude criterion: PaO2 <30 mm Hg)
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
Show all 20Show fewer
- 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 had previous LVR surgery, lung transplantation, lobectomy or other BLVR treatment in either lung.
- Subject has participated in studies to treat COPD using high dose radiation.
- Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
- Subject is chronically 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 any type of antiplatelet or anticoagulant therapy which cannot be stopped for seven (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 been diagnosed with alpha-1 antitrypsin deficiency (AATD).
- 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 with compliance to this study or would adversely affect study outcomes.
Trial locations and contacts
2 sites in 1 country.
About this study
The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.
- Conditions
- Emphysema
- Being tested
- PneumRx Coil System
- Keywords
- RePneu, Coil, LVRC, PneumRx
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumRx Coil SystemDevice
Also called LVRC, RePneu
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients treated with PneumRx Coil System Receives: Device: PneumRx Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 6 Minute Walk Distance (6MWD)
Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.
Measured: Baseline, 12 months post initial treatment
Changes in 6 Minute Walk Distance (6MWD)
Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.
Measured: Baseline, 3 months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start9 Jun 2015
- Primary completion8 Dec 2017
- Study completion20 Oct 2018
Why it stopped: Study enrollment was prematurely stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499380
- Sponsor's protocol ID
- CLN0017
- Status last verified
- Jul 2021
- First submitted
- 27 May 2015
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment
- ClinicalTrials.gov ID
- NCT02499380
- Acronym / sponsor ID
- CLN0017
- Conditions
- Emphysema
- Keywords
- RePneu, Coil, LVRC, PneumRx
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study enrollment was prematurely stopped.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: PneumRx Coil SystemPatients treated with PneumRx Coil System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects diagnosed with emphysematous type of COPD
Key inclusion criteria (8 listed)
- Adult subjects diagnosed with emphysematous type of COPD.
- CT scan indicates bilateral emphysema, with sufficient lung parenchyma for coil deployment (based on PneumRx CT scoring) criteria.
- Subject has post-bronchodilator FEV1 ≤45% predicted.
- Subject has Total Lung Capacity >100% predicted.
- Subject has residual volume (RV) ≥175% predicted.
Key exclusion criteria (20 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 not due to dyspnea.
- Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
- Subject has severe gas exchange abnormalities as defined by:
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
- 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.
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 |
|---|---|---|
| PneumRx Coil SystemAlso: LVRC, RePneu | Device | Treatment |
Primary outcome
Changes in 6 Minute Walk Distance (6MWD)
Time frame: Baseline, 12 months post initial treatment
Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.
Changes in 6 Minute Walk Distance (6MWD)
Time frame: Baseline, 3 months post final treatment
Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema, run by Boston Scientific Corporation at 2 sites in Germany.
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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in 6 Minute Walk Distance (6MWD) (time frame: Baseline, 12 months post initial treatment). The study lists 2 primary outcomes in all. 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 19 Jul 2021.