EmpyhsemaREACHNCT01989182
The Spiration Valve System for the Treatment of Severe Emphysema
A study testing Spiration Valve System and Medical Management in people with Empyhsema and Pulmonary Disease, Chronic Obstructive, run by Olympus Corporation of the Americas at 12 sites in China.
Trial summary
This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Empyhsema, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Spiration Valve System and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 12 sitesChina
- Study dates
- 8 Nov 2013to Mar 2017
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has severe emphysema and high heterogeneity by visual assessment defined as:
- a target lobe with ≥ 40% emphysema involvement and
- ≥ 15% difference with the ipsilateral lobe.
- The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥90% complete after viewing the HRCT in 3 dimensions.
- Patient has received optimal medical management and it has been stable for 6 weeks prior to baseline testing. If pulmonary rehabilitation has been recent, it will be completed at least 3 months prior to baseline testing.
- Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.
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- Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.
- Severe dyspnea defined as a mMRC ≥ 2.
- Patient's obstructive disease is severe as defined by:
- FEV1 ≤ 45% of predicted
- Patient's hyperinflation is defined by:
- TLC ≥ 100% of predicted
- RV ≥ 150% of predicted
- Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.
- Investigator has confirmed that medical management is within standard of care and patient has been stable and without a COPD exacerbation for 6 weeks or more.
Who cannot join
- Patient has severe gas exchange abnormalities as defined by:
- PCO2 > 50 mm Hg (6.6 kPa), or
- PaO2 < 45 mm Hg (6.0 kPa) on room air
- Patient has a BMI < 15 kg/m2 or > 35 kg/m2
- Patient is unable to provide informed consent.
- Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
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- Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
- Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year or has had a COPD exacerbation in the 3 months prior to baseline testing.
- Patient has bronchitis with sputum production > 60 ml per day.
- Patient has an active asthma component to their disease or requires more than 15 mg of prednisone daily (20 mg prednisolone).
- Patient has giant bulla (> 1/3 volume in either lung).
- Patient has severe pulmonary hypertension based upon clinical evaluation.
- A patient with a malignant condition and/or a life threatening disease (other than COPD) that would likely affect the completion of the study
- Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints. This would include neurological or musculoskeletal conditions that may interfere with testing.
- Patient has had prior lung volume reduction surgery or major lung procedures (lobectomy or greater).
- Patient has a lung nodule anticipated to require evaluation or intervention during the 3 month study period.
- Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
- Patient has a diffuse emphysema pattern, diffuse pulmonary fibrosis, or pulmonary tuberculosis (active, extensive, or with adhesive pleural incrassation).
- Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
- Female patient of childbearing potential has a positive result from a pregnancy test required during the 7 days prior to the procedure.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Peking University First Hospital
Beijing
The General Hospital of Chinese People's Liberation Army (301)
Beijing
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
Guangdong General Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The Second Affiliated Hospital ZheJiang University School of Medicine
Hangzhou
Shanghai Chest Hospital
Shanghai
Shanghai Tenth People's Hospital
Shanghai
Zhongshan Hospital Fudan University
Shanghai
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
Tangdu Hospital the Second Teaching Hospital of the Fourth Military Medical University
Xi'an, Shaanxi
About this study
This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.
The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
- Conditions
- Empyhsema, Pulmonary Disease, Chronic Obstructive
- Being tested
- Spiration Valve System, Medical Management
- Keywords
- Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR, TLVR, Emphysema, Pulmonary Emphysema, Pathologic Process, Lung Diseases, Respiratory Tract Disease, China, Spiration Valve System (SVS)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Emphysema, Pathologic Processes, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiration Valve SystemDevice
Medical ManagementOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Spiration Valve System | Experimental | Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. Receives: Device: Spiration Valve System; Other: Medical Management |
| Medical Management | Active comparator | The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure. Receives: Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)
Measured: Baseline and 3 Months
Secondary outcomes (7)
Incidence of device-related serious adverse events
Measured: Baseline and 3 Months
Difference between responder rates in the treatment and control groups, with a responder defined as ≥ 15% improvement in FEV1
Measured: Baseline and 3 Months
Target lobe volume reduction as measured by QCT
Measured: Baseline and 3 Months
Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)
Measured: Baseline and 3 Months
Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)
Measured: Baseline and 3 Months
Exercise capacity as measured by Six Minute Walk Test (6MWT)
Measured: Baseline and 3 Months
Hyperinflation as measured by Residual Volume (RV)
Measured: Baseline and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start8 Nov 2013
- Primary completion18 May 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpyhsemaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Olympus Corporation, Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Nanshan Zhong, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989182
- Sponsor's protocol ID
- TG1226SVS
- Acronym
- REACH
- Status last verified
- Feb 2018
- First submitted
- 6 Nov 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Spiration Valve System for the Treatment of Severe Emphysema
- ClinicalTrials.gov ID
- NCT01989182
- Acronym / sponsor ID
- REACH / TG1226SVS
- Conditions
- Empyhsema, Pulmonary Disease, Chronic Obstructive
- Keywords
- Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Collaborators
- Olympus Corporation, Tigermed Consulting Co., Ltd
- Study start
- 8 Nov 2013 (actual)
- Primary completion
- 18 May 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Nov 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.
This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.
The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Spiration Valve System | Experimental | Device: Spiration Valve System, Other: Medical ManagementSubjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. |
| Medical Management | Active comparator | Other: Medical ManagementThe control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient has severe emphysema and high heterogeneity by visual assessment defined as:
- The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥90% complete after viewing the HRCT in 3 dimensions.
- Patient has received optimal medical management and it has been stable for 6 weeks prior to baseline testing. If pulmonary rehabilitation has been recent, it will be completed at least 3 months prior to baseline testing.
- Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.
- Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.
Key exclusion criteria (21 listed)
- Patient has severe gas exchange abnormalities as defined by:
- Patient has a BMI < 15 kg/m2 or > 35 kg/m2
- Patient is unable to provide informed consent.
- Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
- Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
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 |
|---|---|---|
| Spiration Valve System | Device | Treatment with Spiration Valve System |
| Medical Management | Other | Medical Management, Treatment with Spiration Valve System |
Primary outcome
Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)
Time frame: Baseline and 3 Months
7 secondary outcomes
Incidence of device-related serious adverse events
Time frame: Baseline and 3 Months
Difference between responder rates in the treatment and control groups, with a responder defined as ≥ 15% improvement in FEV1
Time frame: Baseline and 3 Months
Target lobe volume reduction as measured by QCT
Time frame: Baseline and 3 Months
Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)
Time frame: Baseline and 3 Months
Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)
Time frame: Baseline and 3 Months
Exercise capacity as measured by Six Minute Walk Test (6MWT)
Time frame: Baseline and 3 Months
Hyperinflation as measured by Residual Volume (RV)
Time frame: Baseline and 3 Months
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 14 Feb 2018.
Related trials for Empyhsema
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.
Nanshan Zhong, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiration Valve System and Medical Management in people with Empyhsema and Pulmonary Disease, Chronic Obstructive, run by Olympus Corporation of the Americas at 12 sites in China.
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 15 inclusion and 21 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. 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?
Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1) (time frame: Baseline and 3 Months). 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 14 Feb 2018.