EmphysemaPhase 1/2BTSANCT01920321
Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
A Phase 1/2 study testing Endoscopic lung volume reduction in people with Emphysema, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation. Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema
- What is being tested?
- Endoscopic lung volume reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 1/2
- 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
- Age 40-75 unlimited sex. 20 subjects
- COPD, GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.
- 6 minute walking distance > 140 meters.
- -
Who cannot join
- Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.
- Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
- Pregnancy -
Trial locations and contacts
1 site in 1 country.
Isaac Shpirer, MD contact
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Beer Yaakov, 70300
David Stav, MD
About this study
Official title: Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.
Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an inflammatory airway and parenchymal injury and consequently fibrotic response resulting in LVR;
Read the detailed description
Inclusion criteria:
- Age 40-75 unlimited sex. 20 subjects
- chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- total lung capacity(TLC)>110%, residual volume(RV)>150%, diffusion of lung CO(DLCO)<80%,forced expiratory volume 1 second(FEV1):15-45%.
- 6 minute walking distance (6MWD)> 140 meters.
Exclusion criteria:
- Active ischemic heart disease, significant arrhythmia. ejection fraction (EF) <40%.
- COPD that cause carbon bioxide(CO2) retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.5. Pregnancy.
Methods: . A. Patient preparation and sedation as in diagnostic bronchoscopy. Sedation will be based on midzoln + demerol. The patients will be treated prior the treatment with Inhalation with salbutamol ans ipratropium bromide. Flexible bronchoscope with outer diameter 5 mm is introduced to the targated upper lobe, and placed in wedged position. This is followed by installion of 0.9% natriu, chloride(NaCl) at a temperature of 55ºC exit temperature 50ºC) in portions of 40 ml to 200 ml (in bronchoalveolar lavage up to 300 ml is acceptable. The patient is placed in horizontal position, and continuous ECG blood pressure. Oxygen saturation are monitored. This monitoring will be continue at least 2 hours after treatment. A chest x-ray is followed and the patient remain in the department for overnight.
Tracking: Minimum of 6 months - Outpatient follow up include in addition to physical examination extended pulmonary function test and after 3-6 months. low radiation chest CT.
- Conditions
- Emphysema
- Being tested
- Endoscopic lung volume reduction
- Keywords
- COPD, Bronchoscopic LVR, Emphysema, Hot injury
- 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.
Endoscopic lung volume reductionProcedure or surgery
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic lung volume reduction | Experimental | After usual sedation, bronchoscope is introduce to the lung and palced in segmental wedge position then hot salineis instilled. Same procedure to others affected segments. Receives: Procedure: Endoscopic lung volume reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function improvemnt
Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- david Stav, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920321
- Sponsor's protocol ID
- 195/12
- Acronym
- BTSA
- Status last verified
- Aug 2013
- First submitted
- 16 Jul 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel
- ClinicalTrials.gov ID
- NCT01920321
- Acronym / sponsor ID
- BTSA / 195/12
- Conditions
- Emphysema
- Keywords
- COPD, Bronchoscopic LVR, Emphysema, Hot injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Aug 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.
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.
Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an inflammatory airway and parenchymal injury and consequently fibrotic response resulting in LVR;
Detailed description
Inclusion criteria:
- Age 40-75 unlimited sex. 20 subjects
- chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- total lung capacity(TLC)>110%, residual volume(RV)>150%, diffusion of lung CO(DLCO)<80%,forced expiratory volume 1 second(FEV1):15-45%.
- 6 minute walking distance (6MWD)> 140 meters.
Exclusion criteria:
- Active ischemic heart disease, significant arrhythmia. ejection fraction (EF) <40%.
- COPD that cause carbon bioxide(CO2) retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.5. Pregnancy.
Methods: . A. Patient preparation and sedation as in diagnostic bronchoscopy. Sedation will be based on midzoln + demerol. The patients will be treated prior the treatment with Inhalation with salbutamol ans ipratropium bromide. Flexible bronchoscope with outer diameter 5 mm is introduced to the targated upper lobe, and placed in wedged position. This is followed by installion of 0.9% natriu, chloride(NaCl) at a temperature of 55ºC exit temperature 50ºC) in portions of 40 ml to 200 ml (in bronchoalveolar lavage up to 300 ml is acceptable. The patient is placed in horizontal position, and continuous ECG blood pressure. Oxygen saturation are monitored. This monitoring will be continue at least 2 hours after treatment. A chest x-ray is followed and the patient remain in the department for overnight.
Tracking: Minimum of 6 months - Outpatient follow up include in addition to physical examination extended pulmonary function test and after 3-6 months. low radiation chest CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic lung volume reduction | Experimental | Procedure: Endoscopic lung volume reductionAfter usual sedation, bronchoscope is introduce to the lung and palced in segmental wedge position then hot salineis instilled. Same procedure to others affected segments. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40-75 unlimited sex. 20 subjects
- COPD, GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.
- 6 minute walking distance > 140 meters.
Key exclusion criteria (5 listed)
- Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.
- Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
- Pregnancy -
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 |
|---|---|---|
| Endoscopic lung volume reductionPrior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment. | Procedure or surgery | Endoscopic lung volume reduction |
Primary outcome
Pulmonary function improvemnt
Time frame: 6 months
Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Isaac Shpirer, MD contact
david Stav, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Endoscopic lung volume reduction in people with Emphysema, run by Assaf-Harofeh 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 6 inclusion and 5 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 12 Aug 2013. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 David Stav, MD (972- 89779024, dstav@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function improvemnt (time frame: 6 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 12 Aug 2013.