Chronic Obstructive Pulmonary DiseasePhase 3NCT00129584
Endobronchial Valve for Emphysema Palliation Trial (VENT)
A Phase 3 study testing Emphasys Endobronchial Valve and procedure in people with Chronic Obstructive Pulmonary Disease and Emphysema, run by Emphasys Medical.
Trial summary
The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema
- What is being tested?
- Emphasys Endobronchial Valve and procedure
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to not given
- Phase
- Phase 3
- 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
- Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
- Forced expiratory volume in 1 second (FEV1) < 45% predicted
- Total lung capacity (TLC) > 100% predicted
- Residual volume (RV) > 150% predicted
- Post rehabilitation 6 minute walk test > 140m
- Non-smoking for 4 months
Who cannot join
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
- History of recurrent respiratory infections
- Evidence of large bullae (>30% of either lung) in a non-target lobe
- FEV1 < 15% predicted
- Diffusing capacity for carbon monoxide (DLCO) < 20% predicted
About this study
The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.
Read the detailed description
Background:
Emphysema, caused primarily by smoking, is characterized by the gradual, irreversible breakdown of tissue and loss of elastic recoil within the lungs, causing them to lose the ability to expel air and efficiently absorb oxygen. As this chronic condition inexorably progresses, the diseased, hyperinflated areas of the lung eventually fill the chest cavity, leaving less and less volume available for the viable lung tissue.
Lung volume reduction surgery (LVRS) has been shown to offer relief to patients suffering from emphysema when other treatment options fail. Researchers have continued to refine both technique and patient selection in order to improve outcomes. The objective of lung volume reduction is to eliminate dysfunctional, over-inflated regions of lung. Results similar to surgical removal have been obtained by plication (folding) and stapling without tissue removal. These results suggest that isolation of the dysfunctional lung region can achieve similar results to tissue removal.
The paradoxical effect of improving lung function by removing (or isolating) lung tissue demonstrates that breathlessness due to emphysema is a function of mechanical inefficiencies in addition to loss of gas-transfer surface area and other physiological mechanisms. At least in some patients, the mechanical compromise is the primary cause of their pulmonary incapacitation and these patients can benefit by addressing their inability to effectively inhale and exhale. Because LVRS reduces trapped gas, others have speculated that results similar to LVRS could be achieved bronchoscopically by reducing the volume of the hyperinflated regions with, or without, atelectasis.
Emphasys has developed a bronchoscopic approach to block inspiratory airflow into targeted, hyperinflated regions of the lung, while permitting exhaled gas to escape. This approach may lead to lung volume reduction and provide some of the clinical benefits of LVRS without the high risks and costs associated with such an invasive surgical procedure.
Comparison:
The primary object of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Being tested
- Emphasys Endobronchial Valve and procedure
- Keywords
- Endobronchial Valve (EBV) Procedure, Bronchoscopic Lung Volume Reduction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emphasys Endobronchial Valve and procedureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function testing at various time points through one year
Exercise tolerance at various time points through one year
Major complications at various time points through one year
Secondary outcomes (3)
Pulmonary function testing at various time points through one year
Quality of life measures at various time points through one year
Other adverse event rates at various time points through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- Emphasys Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank C Sciurba, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129584
- Sponsor's protocol ID
- 630-0001
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2005
- Last updated
- 18 Aug 2009
- Results posted
- No
Publications
Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
PubMed 14999112Sciurba FC, Rogers RM, Keenan RJ, Slivka WA, Gorcsan J 3rd, Ferson PF, Holbert JM, Brown ML, Landreneau RJ. Improvement in pulmonary function and elastic recoil after lung-reduction surgery for diffuse emphysema. N Engl J Med. 1996 Apr 25;334(17):1095-9. doi: 10.1056/NEJM199604253341704.
PubMed 8598868Martinez FJ, de Oca MM, Whyte RI, Stetz J, Gay SE, Celli BR. Lung-volume reduction improves dyspnea, dynamic hyperinflation, and respiratory muscle function. Am J Respir Crit Care Med. 1997 Jun;155(6):1984-90. doi: 10.1164/ajrccm.155.6.9196106.
PubMed 9196106Sabanathan A, Sabanathan S, Shah R, Richardson J. Lung volume reduction surgery for emphysema. A review. J Cardiovasc Surg (Torino). 1998 Apr;39(2):237-43.
PubMed 9639013Geddes D, Davies M, Koyama H, Hansell D, Pastorino U, Pepper J, Agent P, Cullinan P, MacNeill SJ, Goldstraw P. Effect of lung-volume-reduction surgery in patients with severe emphysema. N Engl J Med. 2000 Jul 27;343(4):239-45. doi: 10.1056/NEJM200007273430402.
PubMed 10911005Gelb AF, McKenna RJ Jr, Brenner M, Schein MJ, Zamel N, Fischel R. Lung function 4 years after lung volume reduction surgery for emphysema. Chest. 1999 Dec;116(6):1608-15. doi: 10.1378/chest.116.6.1608.
PubMed 10593784Gierada DS, Yusen RD, Villanueva IA, Pilgram TK, Slone RM, Lefrak SS, Cooper JD. Patient selection for lung volume reduction surgery: An objective model based on prior clinical decisions and quantitative CT analysis. Chest. 2000 Apr;117(4):991-8. doi: 10.1378/chest.117.4.991.
PubMed 10767229Russi EW, Bloch KE, Weder W. Functional and morphological heterogeneity of emphysema and its implication for selection of patients for lung volume reduction surgery. Eur Respir J. 1999 Jul;14(1):230-6. doi: 10.1034/j.1399-3003.1999.14a39.x.
PubMed 10489857Rogers RM, Coxson HO, Sciurba FC, Keenan RJ, Whittall KP, Hogg JC. Preoperative severity of emphysema predictive of improvement after lung volume reduction surgery: use of CT morphometry. Chest. 2000 Nov;118(5):1240-7. doi: 10.1378/chest.118.5.1240.
PubMed 11083670Gelb AF, Zamel N, McKenna RJ Jr, Brenner M. Mechanism of short-term improvement in lung function after emphysema resection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):945-51. doi: 10.1164/ajrccm.154.4.8887590.
PubMed 8887590Swanson SJ, Mentzer SJ, DeCamp MM Jr, Bueno R, Richards WG, Ingenito EP, Reilly JJ, Sugarbaker DJ. No-cut thoracoscopic lung plication: a new technique for lung volume reduction surgery. J Am Coll Surg. 1997 Jul;185(1):25-32. doi: 10.1016/s1072-7515(97)00021-5.
PubMed 9208957Hoppin FG Jr. Theoretical basis for improvement following reduction pneumoplasty in emphysema. Am J Respir Crit Care Med. 1997 Feb;155(2):520-5. doi: 10.1164/ajrccm.155.2.9032188.
PubMed 9032188Iwasaki M, Nishiumi N, Kaga K, Kanazawa M, Kuwahira I, Inoue H. Application of the fold plication method for unilateral lung volume reduction in pulmonary emphysema. Ann Thorac Surg. 1999 Mar;67(3):815-7. doi: 10.1016/s0003-4975(98)01302-2.
PubMed 10215234Kuwahira I, Iwasaki M, Kaga K, Iwamoto T, Tazaki G, Ishii M, Inoue H, Ohta Y. Effectiveness of the fold plication method in lung volume reduction surgery. Intern Med. 2000 May;39(5):381-4. doi: 10.2169/internalmedicine.39.381.
PubMed 10830177Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, Weinmann G, Wood DE; National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003 May 22;348(21):2059-73. doi: 10.1056/NEJMoa030287. Epub 2003 May 20.
PubMed 12759479
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Valve for Emphysema Palliation Trial (VENT)
- ClinicalTrials.gov ID
- NCT00129584
- Acronym / sponsor ID
- 630-0001
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Keywords
- Endobronchial Valve (EBV) Procedure, Bronchoscopic Lung Volume Reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- Emphasys MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- First posted
- 12 Aug 2005 (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 this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.
Detailed description
Background:
Emphysema, caused primarily by smoking, is characterized by the gradual, irreversible breakdown of tissue and loss of elastic recoil within the lungs, causing them to lose the ability to expel air and efficiently absorb oxygen. As this chronic condition inexorably progresses, the diseased, hyperinflated areas of the lung eventually fill the chest cavity, leaving less and less volume available for the viable lung tissue.
Lung volume reduction surgery (LVRS) has been shown to offer relief to patients suffering from emphysema when other treatment options fail. Researchers have continued to refine both technique and patient selection in order to improve outcomes. The objective of lung volume reduction is to eliminate dysfunctional, over-inflated regions of lung. Results similar to surgical removal have been obtained by plication (folding) and stapling without tissue removal. These results suggest that isolation of the dysfunctional lung region can achieve similar results to tissue removal.
The paradoxical effect of improving lung function by removing (or isolating) lung tissue demonstrates that breathlessness due to emphysema is a function of mechanical inefficiencies in addition to loss of gas-transfer surface area and other physiological mechanisms. At least in some patients, the mechanical compromise is the primary cause of their pulmonary incapacitation and these patients can benefit by addressing their inability to effectively inhale and exhale. Because LVRS reduces trapped gas, others have speculated that results similar to LVRS could be achieved bronchoscopically by reducing the volume of the hyperinflated regions with, or without, atelectasis.
Emphasys has developed a bronchoscopic approach to block inspiratory airflow into targeted, hyperinflated regions of the lung, while permitting exhaled gas to escape. This approach may lead to lung volume reduction and provide some of the clinical benefits of LVRS without the high risks and costs associated with such an invasive surgical procedure.
Comparison:
The primary object of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
- Forced expiratory volume in 1 second (FEV1) < 45% predicted
- Total lung capacity (TLC) > 100% predicted
- Residual volume (RV) > 150% predicted
- Post rehabilitation 6 minute walk test > 140m
Key exclusion criteria (5 listed)
- Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
- History of recurrent respiratory infections
- Evidence of large bullae (>30% of either lung) in a non-target lobe
- FEV1 < 15% predicted
- Diffusing capacity for carbon monoxide (DLCO) < 20% predicted
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 |
|---|---|---|
| Emphasys Endobronchial Valve and procedure | Procedure or surgery | – |
Primary outcome
Pulmonary function testing at various time points through one year
Exercise tolerance at various time points through one year
Major complications at various time points through one year
3 secondary outcomes
Pulmonary function testing at various time points through one year
Quality of life measures at various time points through one year
Other adverse event rates at various time points through one year
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 18 Aug 2009.
- Background: PubMed 14999112Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
- Background: PubMed 8598868Sciurba FC, Rogers RM, Keenan RJ, Slivka WA, Gorcsan J 3rd, Ferson PF, Holbert JM, Brown ML, Landreneau RJ. Improvement in pulmonary function and elastic recoil after lung-reduction surgery for diffuse emphysema. N Engl J Med. 1996 Apr 25;334(17):1095-9. doi: 10.1056/NEJM199604253341704.
- Background: PubMed 9196106Martinez FJ, de Oca MM, Whyte RI, Stetz J, Gay SE, Celli BR. Lung-volume reduction improves dyspnea, dynamic hyperinflation, and respiratory muscle function. Am J Respir Crit Care Med. 1997 Jun;155(6):1984-90. doi: 10.1164/ajrccm.155.6.9196106.
- Background: PubMed 9639013Sabanathan A, Sabanathan S, Shah R, Richardson J. Lung volume reduction surgery for emphysema. A review. J Cardiovasc Surg (Torino). 1998 Apr;39(2):237-43.
- Background: PubMed 10911005Geddes D, Davies M, Koyama H, Hansell D, Pastorino U, Pepper J, Agent P, Cullinan P, MacNeill SJ, Goldstraw P. Effect of lung-volume-reduction surgery in patients with severe emphysema. N Engl J Med. 2000 Jul 27;343(4):239-45. doi: 10.1056/NEJM200007273430402.
- Background: PubMed 10593784Gelb AF, McKenna RJ Jr, Brenner M, Schein MJ, Zamel N, Fischel R. Lung function 4 years after lung volume reduction surgery for emphysema. Chest. 1999 Dec;116(6):1608-15. doi: 10.1378/chest.116.6.1608.
- Background: PubMed 10767229Gierada DS, Yusen RD, Villanueva IA, Pilgram TK, Slone RM, Lefrak SS, Cooper JD. Patient selection for lung volume reduction surgery: An objective model based on prior clinical decisions and quantitative CT analysis. Chest. 2000 Apr;117(4):991-8. doi: 10.1378/chest.117.4.991.
- Background: PubMed 10489857Russi EW, Bloch KE, Weder W. Functional and morphological heterogeneity of emphysema and its implication for selection of patients for lung volume reduction surgery. Eur Respir J. 1999 Jul;14(1):230-6. doi: 10.1034/j.1399-3003.1999.14a39.x.
- Background: PubMed 11083670Rogers RM, Coxson HO, Sciurba FC, Keenan RJ, Whittall KP, Hogg JC. Preoperative severity of emphysema predictive of improvement after lung volume reduction surgery: use of CT morphometry. Chest. 2000 Nov;118(5):1240-7. doi: 10.1378/chest.118.5.1240.
- Background: PubMed 8887590Gelb AF, Zamel N, McKenna RJ Jr, Brenner M. Mechanism of short-term improvement in lung function after emphysema resection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):945-51. doi: 10.1164/ajrccm.154.4.8887590.
- Background: PubMed 9208957Swanson SJ, Mentzer SJ, DeCamp MM Jr, Bueno R, Richards WG, Ingenito EP, Reilly JJ, Sugarbaker DJ. No-cut thoracoscopic lung plication: a new technique for lung volume reduction surgery. J Am Coll Surg. 1997 Jul;185(1):25-32. doi: 10.1016/s1072-7515(97)00021-5.
- Background: PubMed 9032188Hoppin FG Jr. Theoretical basis for improvement following reduction pneumoplasty in emphysema. Am J Respir Crit Care Med. 1997 Feb;155(2):520-5. doi: 10.1164/ajrccm.155.2.9032188.
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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.
Frank C Sciurba, MD principal investigator
University of Pittsburgh Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Emphasys Endobronchial Valve and procedure in people with Chronic Obstructive Pulmonary Disease and Emphysema, run by Emphasys Medical.
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: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pulmonary function testing at various time points through one year. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129584, which also lists 20 linked publications.
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 18 Aug 2009.