Clinical trial · Interventional
Endobronchial Valve for Emphysema Palliation Trial (VENT)
NCT00129584CI-TRIAL-00002553completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Emphysema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Emphasys Endobronchial Valve and procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Pulmonary function testing at various time points through one year
- measure
- Exercise tolerance at various time points through one year
- measure
- Major complications at various time points through one year
Secondary outcomes (3)
- measure
- Pulmonary function testing at various time points through one year
- measure
- Quality of life measures at various time points through one year
- measure
- Other adverse event rates at various time points through one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (20)
- BACKGROUNDCelli 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. PMID 14999112
- BACKGROUNDSciurba 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. PMID 8598868
- BACKGROUNDMartinez 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. PMID 9196106
- BACKGROUNDSabanathan 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. PMID 9639013
- BACKGROUNDGeddes 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. PMID 10911005
- BACKGROUNDGelb 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. PMID 10593784
- BACKGROUNDGierada 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.