Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to EmphysemaNCT01682018
The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
A study testing lung volume reduction using the Zephyr device in people with Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema
- What is being tested?
- lung volume reduction using the Zephyr device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation
- Age from 40 to 75 years
- BMI < 32 kg/m2
- FEV1 < 40% of predicted value, FEV1/FVC < 70%
- TLC > 120% predicted, RV > 150% predicted.
- Stable with < 20 mg prednisone (or equivalent) qd
Show all 32Show fewer
- PaCO2 < 50mm Hg
- PaO2 > 45 mm Hg on room air
- 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation)
- Nonsmoking for 4 months prior to initial interview and throughout screening
- The patient agrees to all protocol required follow-up intervals.
- The patient has no child bearing potential
- The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria
- Prior endobronchial treatment for emphysema
- Pleural or interstitial disease that precludes surgery.
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
- Clinically significant bronchiectasis
- Pulmonary nodule requiring surgery
- History of recurrent respiratory infections (> 3 hospitalization in the last year)
- Clinically significant (> 4 Tablespoons per day) sputum production
- Fever, elevated white cell count, or other evidence of active infection
- Dysrhythmia that might pose a risk during exercise or training
- Congestive heart failure within 6 mo and LVEF < 45%
- Evidence or history of Cor Pulmonale
- Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
- History of exercise-related syncope
- MI within 6 mo and LVEF < 45%
- Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period
- Any disease or condition that interferes with completion of initial or follow-up assessments
- Patient is currently enrolled in another clinical trial
- Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer
- Alpha-1-Antitrypsin Deficiency
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva, Israel, 92100
Mordechai R Kramer, MD, 97239377140, kremerm@clalit.org.il
About this study
Official title: Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests.
Read the detailed description
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR.
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests
- Conditions
- Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema
- Being tested
- lung volume reduction using the Zephyr device
- Keywords
- emphysema, lung transplantation
- 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 using the Zephyr deviceDevice
lung volume reduction using the Zephyr device
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung Receives: Device: lung volume reduction using the Zephyr device |
What is being measured
The primary outcome is the main question the study is designed to answer.
•Mean % change in lung function (FEV1)
Measured: 90 days
Secondary outcomes (1)
Mean change in six minutes walk distance
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682018
- Sponsor's protocol ID
- RMC126908
- Status last verified
- Jul 2012
- First submitted
- 5 Sep 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
- ClinicalTrials.gov ID
- NCT01682018
- Acronym / sponsor ID
- RMC126908
- Conditions
- Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema
- Keywords
- emphysema, lung transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 10 Sep 2012 (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 purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests.
Detailed description
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR.
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: lung volume reduction using the Zephyr devicePatients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation
- Age from 40 to 75 years
- BMI < 32 kg/m2
- FEV1 < 40% of predicted value, FEV1/FVC < 70%
- TLC > 120% predicted, RV > 150% predicted.
Key exclusion criteria (0 listed)
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 using the Zephyr devicelung volume reduction using the Zephyr device | Device | intervention group |
Primary outcome
•Mean % change in lung function (FEV1)
Time frame: 90 days
1 secondary outcome
Mean change in six minutes walk distance
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung volume reduction using the Zephyr device in people with Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema, run by Rabin Medical Center at 1 site in Israel.
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 32 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 10 Sep 2012. 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 Israel. 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?
Contact Mordechai Kramer Kramer, MD (97239377140, Kremerm@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
•Mean % change in lung function (FEV1) (time frame: 90 days). 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 10 Sep 2012.