EmphysemaNCT03685526
Cinenses Lung Volume Reduction Reverser System First-in-man Study Treating Patients With Severe Emphysema
A study testing Cinenses Lung Volume Reduction Reverser System in people with Emphysema, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Germany.
Trial summary
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Emphysema
- What is being tested?
- Cinenses Lung Volume Reduction Reverser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 6 May 2019to 1 Aug 2022
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Candidates for this study must meet all of the following inclusion criteria:
- Patient between 50 to 80 years old
- High Resolution CT scan indicates homogeneous or heterogeneous emphysema.
- Patient has post- bronchodilator FEV1 less than or equal to 45% of predicted
- Total Lung Capacity > 100% of predicted.
- Residual volume≥ 200% of predicted.
- Patient has marked dyspnea scoring >2 on mMRC scale of 0-4.
- Patient has stopped smoking for a minimum of 8 weeks prior to entering the study, as confirmed by COHb ≤2.5%
- Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form.
- Subject has completed a pulmonary rehab within the last year and/or performs regularly physical activity.
Candidates will be excluded from the study if any of the following conditions are present:
- Patient has a change in FEV1 > 20% post-bronchodilator
- Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
- Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure>50mmHg and/or evidenced by echocardiogram.
- Patient has an inability to walk >140 meters (150 yards) in 6 minutes.
- Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified such evidences.
- Patient is pregnant or lactating.
- Patient has an inability to tolerate bronchoscopy under anesthesia.
- Any contraindication to bronchoscopy procedure, including but not limited to:
- Untreatable life-threatening arrhythmias
- Inability to adequately oxygenate the patient during the procedure
- Acute respiratory failure with hypercapnia
- Within 6 months myocardial infarction
- Previously diagnosed high-grade tracheal obstruction
- Uncorrectable coagulopathy
- Patient has clinically significant bronchiectasis.
- Patient has giant bullae > 1/3 lung volume.
- Patient has had previous LVR surgery, lung transplant or lobectomy,or has still ELVR devices or other device to treat COPD in either lung.
- Patient has been involved in other clinical studies within 30 days prior to this study.
- Patient is taking > 20mg prednisone (or similar steroid) daily.
- Patient on antiplatelet agent (eg, clopidogrel) or anticoagulant therapy (eg, heparin or coumadin) or has not been weaned off prior to procedure.
- Patient has any other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes.
- A known allergy to nitinol.
- Patient with uncontrolled diabetes as well as overweight patient (BMI > 35 kg/m2)
- Cancer needs chemotherapy in past two years
- Patient with pleural effusion and/or pneumothorax
- Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD), active tuberculosis;
- Patient with exacerbation of chronic obstructive pulmonary disease (COPD) which defined as: An acute event with the need of antibiotic treatment or hospitalization.
- Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mm Hg,PaO2 <45 mm Hg on room air
- Patient with acute ischemic heart disease, with proven pulmonary hypertension (SPAP> 45 mmHg) in echocardiography and/or need for double platelet aggregation inhibition
Trial locations and contacts
1 site in 1 country.
Germany1 site
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, D-69126
About this study
Official title: Evaluation of the Cinenses Lung Volume Reduction Reverser System in Treating Patients With Severe Emphysema
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness.
Read the detailed description
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness. Study Population :Patients with severe emphysema and have to meet all the inclusion and exclusion criteria.
Sample Size: 15 subjects
- Conditions
- Emphysema
- Being tested
- Cinenses Lung Volume Reduction Reverser System
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinenses Lung Volume Reduction Reverser SystemDevice
Lung Volume Reduction Reverser System is show as figure 1-4, consists of lung volume reduction reverser (short as: reverser), conveyor, measuring guide wire and transporting sheath. Matrix of reverser is nickel titanium alloy, its surface is coated by polymer flexible film, at the end of the connection segment is specially designed connector, which is easy for the reverser's transport and recycling. The silica gel part at the far end of reverser makes it softer.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Patients will be treated with Cinenses Lung Volume Reduction Reverser System. Receives: Device: Cinenses Lung Volume Reduction Reverser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Evaluate adverse events associated with implantation of the Cinenses Lung Volume Reduction Reverser System at 3-month post final bronchoscopy. CinensesTMLung Volume Reduction Reverser System at 3-month post final bronchoscopy.
Measured: 3-month post final bronchoscopy
Secondary outcomes (7)
Device success (Device level)
Device success was defined as successful delivery and deployment of the study device at the intended target position and successful withdrawal of the delivery system.
Measured: immediate postoperative
Procedural success
Procedural success was defined as all the study devices that were intended to be used during one procedure were achieved device success and the subject was without the occurrence of device-related or procedure-related SAEs during the hospital stay
Measured: during the hospital stay
St. George's Respiratory Questionnaire (SGRQ) score
The improvement of St. George's Respiratory Questionnaire (SGRQ) score from baseline (Pre-Treatment Visit) to 1-, 3- and 6-month ,12-month follow-up.
Measured: 1,3,6-month,12-month follow-up
Percent change in forced expiratory volume in 1 second
Percent change in forced expiratory volume in 1 second (FEV1) from baseline (Pre- Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up.
Measured: 1,3,6-month,12-month follow-up
Decrease in the Residual Volume (RV)
Decrease in the Residual Volume (RV) from baseline (Pre-Treatment Visit) compared to
1-, 3- and 6-month,12-month follow-up.
Measured: 1,3,6-month,12-month follow-up
Improvement in the 6-minute walk test
Improvement in the 6-minute walk test from baseline (Pre-Treatment Visit) compared to
1-, 3- and 6-month,12-month follow-up
Measured: 1,3,6-month,12-month follow-up
Improvement in the mMRC dyspnea scale
Improvement in the mMRC dyspnea scale from baseline (Pre-Treatment Visit) compared to 1-, 3- and 6-month,12-month follow-up.
Measured: 1,3,6-month,12-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 posted26 Sep 2018
- Study start6 May 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Herth, Principal investigator, Thoraxklinik-Heidelberg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685526
- Sponsor's protocol ID
- LVR-EU-FIM-01
- Status last verified
- Jun 2021
- First submitted
- 17 Sep 2018
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cinenses Lung Volume Reduction Reverser System in Treating Patients With Severe Emphysema
- ClinicalTrials.gov ID
- NCT03685526
- Acronym / sponsor ID
- LVR-EU-FIM-01
- Conditions
- Emphysema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 26 Sep 2018 (actual)
- 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 study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness.
Detailed description
The study is designed as a prospective, nonrandomized, exploratory, single center, first-in-man study. The objective of this study is to evaluate its safety and feasibility of the CinensesTM Lung Volume Reduction Reverser System in patients with severe emphysema. The study will also collect clinical data up to 6-month follow-up to explore its safety and effectiveness. Study Population :Patients with severe emphysema and have to meet all the inclusion and exclusion criteria.
Sample Size: 15 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Cinenses Lung Volume Reduction Reverser SystemPatients will be treated with Cinenses Lung Volume Reduction Reverser System. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cinenses Lung Volume Reduction Reverser SystemLung Volume Reduction Reverser System is show as figure 1-4, consists of lung volume reduction reverser (short as: reverser), conveyor, measuring guide wire and transporting sheath. Matrix of reverser is nickel titanium alloy, its surface is coated by polymer flexible film, at the end of the connection segment is specially designed connector, which is easy for the reverser's transport and recycling. The silica gel part at the far end of reverser makes it softer. | Device | Interventional arm |
Primary outcome
Incidence of adverse events
Time frame: 3-month post final bronchoscopy
Evaluate adverse events associated with implantation of the Cinenses Lung Volume Reduction Reverser System at 3-month post final bronchoscopy. CinensesTMLung Volume Reduction Reverser System at 3-month post final bronchoscopy.
7 secondary outcomes
Device success (Device level)
Time frame: immediate postoperative
Procedural success
Time frame: during the hospital stay
St. George's Respiratory Questionnaire (SGRQ) score
Time frame: 1,3,6-month,12-month follow-up
Percent change in forced expiratory volume in 1 second
Time frame: 1,3,6-month,12-month follow-up
Decrease in the Residual Volume (RV)
Time frame: 1,3,6-month,12-month follow-up
Improvement in the 6-minute walk test
Time frame: 1,3,6-month,12-month follow-up
Improvement in the mMRC dyspnea scale
Time frame: 1,3,6-month,12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Felix Herth principal investigator
Thoraxklinik-Heidelberg gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinenses Lung Volume Reduction Reverser System in people with Emphysema, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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 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?
Results are not available in the source record.
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?
Incidence of adverse events (time frame: 3-month post final bronchoscopy). 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 29 Jun 2021; AzTrials last refreshed its copy on 29 Oct 2026.