EmphysemaPhase 1NCT01334307
Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)
A Phase 1 study testing Lung Volume Reduction Coil (LVRC) (PneumRx) in people with Emphysema, run by Boston Scientific Corporation at 3 sites in United Kingdom.
Trial summary
The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Lung Volume Reduction Coil (LVRC) (PneumRx)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 2010to Sep 2013
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient greater than or equal to 35 years of age
- High resolution CT scan indicates unilateral or bilateral emphysema
- High resolution CT scan indicates homogeneous or heterogeneous emphysema
- Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
- Total Lung Capacity greater than 100% predicted
- Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
- Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
- Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form
Who cannot join
- Patient has a change in FEV1 greater than 20% post-bronchodilator
- Patients DLCO less than 20% predicted
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
- Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
- Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
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- Patient is pregnant or lactating
- Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
- Patient has clinically significant bronchiectasis
- Patient has giant bullae greater than 1/3 lung volume
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug studies with 30 days prior to this study
- Patient is taking greater than 20 mg prednisone (or similar steroid) daily
- Patient is on Plavix or has not been weaned off prior to procedure
- Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Study site
Glasgow
Chelsea and Westminster Hospital
London
Study site
Manchester
About this study
Official title: Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.
- Conditions
- Emphysema
- Being tested
- Lung Volume Reduction Coil (LVRC) (PneumRx), Control
- Keywords
- Emphysema, RePneu
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Volume Reduction Coil (LVRC) (PneumRx)Device
Also called LVRD
Lung Volume Reduction Coil (LVRC)
ControlDevice
Also called LVRC Control treatment is Standard of Care
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Lung Volume Reduction Coil (LVRC) | Experimental | Lung Volume Reduction Coil (LVRC) Receives: Device: Lung Volume Reduction Coil (LVRC) (PneumRx) |
| Control | Placebo comparator | Standard of Care Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. George's Respiratory Questionnaire (SGRQ)
The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.
Measured: three month Follow-Up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Pallav Shah, MD, Principal investigator, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334307
- Sponsor's protocol ID
- CLN0008
- Status last verified
- Jul 2021
- First submitted
- 1 Apr 2011
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL. Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015.
PubMed 25853697Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.
PubMed 24429129
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)
- ClinicalTrials.gov ID
- NCT01334307
- Acronym / sponsor ID
- CLN0008
- Conditions
- Emphysema
- Keywords
- Emphysema, RePneu
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Apr 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 objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Volume Reduction Coil (LVRC) | Experimental | Device: Lung Volume Reduction Coil (LVRC) (PneumRx)Lung Volume Reduction Coil (LVRC) |
| Control | Placebo comparator | Device: ControlStandard of Care |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient greater than or equal to 35 years of age
- High resolution CT scan indicates unilateral or bilateral emphysema
- High resolution CT scan indicates homogeneous or heterogeneous emphysema
- Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
- Total Lung Capacity greater than 100% predicted
Key exclusion criteria (15 listed)
- Patient has a change in FEV1 greater than 20% post-bronchodilator
- Patients DLCO less than 20% predicted
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
- Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
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 |
|---|---|---|
| Lung Volume Reduction Coil (LVRC) (PneumRx)Also: LVRDLung Volume Reduction Coil (LVRC) | Device | Lung Volume Reduction Coil (LVRC) |
| ControlAlso: LVRC Control treatment is Standard of CareStandard of Care | Device | Control |
Primary outcome
St. George's Respiratory Questionnaire (SGRQ)
Time frame: three month Follow-Up Visit
The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.
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 21 Jul 2021.
- Derived from this study: PubMed 25853697Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL. Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015.
- Derived from this study: PubMed 24429129Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.
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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.
Pallav Shah, MD principal investigator
Chelsea and Westminster Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lung Volume Reduction Coil (LVRC) (PneumRx) in people with Emphysema, run by Boston Scientific Corporation at 3 sites in United Kingdom.
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 15 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 21 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 3 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
St. George's Respiratory Questionnaire (SGRQ) (time frame: three month Follow-Up Visit). 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 NCT01334307, which also lists 2 linked publications.
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 21 Jul 2021.