Emphysema or COPDEFFORTNCT04520152
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema
A study testing FreeFlowMedical Lung Tensioning Device in people with Emphysema or COPD, run by University Medical Center Groningen at 2 sites in 2 countries.
Trial summary
Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Emphysema or COPD
- What is being tested?
- FreeFlowMedical Lung Tensioning Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jun 2021to 8 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- FEV1/FVC ≤ 70%
- ≥ 40 years of age
- Post-bronchodilator FEV1 ≤ 45% of predicted
- Total Lung Capacity > 100% of predicted
- Residual Volume (RV) > 175% of predicted
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- RV/TLC > 55%
- Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
- Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s)
- Stopped smoking for ≥ 6 months prior to entering the study
- Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy
- Ability to read, understand and sign the informed consent form
Who cannot join
- History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
- History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
- Clinically significant bronchiectasis
- Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
- ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
- Inability to walk > 140 meters in 6 minutes
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- Known pulmonary hypertension defined by right ventricular systolic pressure > 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
- Significant paraseptal emphysema
- Giant bullae (>1/3 of lung volume)
- Medical history of asthma
- Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
- Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
- Evidence of other disease(s) that have a predicted survival of less than one year
- Inability to tolerate bronchoscopy under general anaesthesia
- Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy (such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be permanently stopped prior to entering the study
- Pregnant, lactating or plans to become pregnant within the study timeframe
- Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia
- 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
- Known Nickel, Titanium, or Nitinol allergy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Dept. of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg
Heidelberg, Baden-Wurttemberg, D-69126
About this study
Official title: Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT
Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.
- Conditions
- Emphysema or COPD
- Being tested
- FreeFlowMedical Lung Tensioning Device
- Keywords
- lung volume reduction, nitinol, device
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeFlowMedical Lung Tensioning DeviceDevice
Bronchoscopic lung tensioning device implantation
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Bronchoscopic LTD placement Receives: Device: FreeFlowMedical Lung Tensioning Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: type and frequency of device-related and procedure-related AE
To evaluate the safety of the LTD in COPD patients with heterogeneous and homogeneous emphysema by evaluating the type and frequency of device-related and procedure-related AE experienced during and following LTD placement through the 3-month visit.
Measured: 3 months
Procedural succes
To evaluate the feasibility of the LTD in COPD patients with heterogeneous and homogeneous emphysema by measuring the frequencies of successful and unsuccessful intended LTD placements.
Measured: 3 months
Secondary outcomes (1)
Performance - Quality of Life: St George's Respiratory Questionnaire
Change in St George's Respiratory Questionnaire total score
Measured: 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 Aug 2020
- Study start23 Jun 2021
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emphysema or COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520152
- Sponsor's protocol ID
- EFFORT
- Acronym
- EFFORT
- Status last verified
- Nov 2023
- First submitted
- 17 Aug 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT
- ClinicalTrials.gov ID
- NCT04520152
- Acronym / sponsor ID
- EFFORT / EFFORT
- Conditions
- Emphysema or COPD
- Keywords
- lung volume reduction, nitinol, device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 20 Aug 2020 (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.
Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: FreeFlowMedical Lung Tensioning DeviceBronchoscopic LTD placement |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of COPD
- FEV1/FVC ≤ 70%
- ≥ 40 years of age
- Post-bronchodilator FEV1 ≤ 45% of predicted
- Total Lung Capacity > 100% of predicted
Key exclusion criteria (19 listed)
- History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
- History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
- Clinically significant bronchiectasis
- Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
- ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
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 |
|---|---|---|
| FreeFlowMedical Lung Tensioning DeviceBronchoscopic lung tensioning device implantation | Device | Treatment group |
Primary outcome
Safety: type and frequency of device-related and procedure-related AE
Time frame: 3 months
To evaluate the safety of the LTD in COPD patients with heterogeneous and homogeneous emphysema by evaluating the type and frequency of device-related and procedure-related AE experienced during and following LTD placement through the 3-month visit.
Procedural succes
Time frame: 3 months
To evaluate the feasibility of the LTD in COPD patients with heterogeneous and homogeneous emphysema by measuring the frequencies of successful and unsuccessful intended LTD placements.
1 secondary outcome
Performance - Quality of Life: St George's Respiratory Questionnaire
Time frame: 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 21 Nov 2023.
- Individual participant dataSharing planned: No
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeFlowMedical Lung Tensioning Device in people with Emphysema or COPD, run by University Medical Center Groningen at 2 sites in 2 countries.
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 12 inclusion and 19 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 Nov 2023. 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, Netherlands. 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?
Safety: type and frequency of device-related and procedure-related AE (time frame: 3 months). 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 21 Nov 2023.