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EmphysemaPhase 3NCT00137956

Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

A Phase 3 study testing Emphasys Endobronchial Valve (EBV) Device and Procedure in people with Emphysema and Chronic Obstructive Pulmonary Disease, run by Emphasys Medical.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Emphasys Endobronchial Valve (EBV) Device and Procedure
Type of treatment
Medical device
How many people
270 participants
Where
No sites listed yet
Study dates
Dec 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, lung volume reduction surgery (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 of the lung for carbon monoxide (DLCO) < 20% predicted

About this study

The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.

Read the detailed description

Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. In the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time.

Questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. In 1993, the Department of Health and Human Services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. The panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. These analyses require preference-weighted measures of health-related quality of life. Such measures are needed in order to adjust survival time for health-related quality of life.

Being tested
Emphasys Endobronchial Valve (EBV) Device and Procedure
Keywords
Endobronchial Valve, Endobronchial Valve ProcedureEBV, EBV Procedure, Endobronchial Lung Volume Reduction, Lung Volume Reduction
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.

  • Emphasys Endobronchial Valve (EBV) Device and ProcedureDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days

Secondary outcomes (1)

  1. The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study startDec 2004

Resources

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00137956
Sponsor's protocol ID
630-0005
Status last verified
Aug 2009
First submitted
26 Aug 2005
Last updated
18 Aug 2009
Results posted
No

Publications

  • Gold M, Franks P, Erickson P. Assessing the health of the nation. The predictive validity of a preference-based measure and self-rated health. Med Care. 1996 Feb;34(2):163-77. doi: 10.1097/00005650-199602000-00008.

    PubMed 8632690

  • Feeny D, Furlong W, Boyle M, Torrance GW. Multi-attribute health status classification systems. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):490-502. doi: 10.2165/00019053-199507060-00004.

    PubMed 10155335

  • Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics. 2000 Nov;18(5):419-23. doi: 10.2165/00019053-200018050-00001.

    PubMed 11151395

  • Torrance GW, Furlong W, Feeny D, Boyle M. Multi-attribute preference functions. Health Utilities Index. Pharmacoeconomics. 1995 Jun;7(6):503-20. doi: 10.2165/00019053-199507060-00005.

    PubMed 10155336

  • Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. doi: 10.1016/s0895-4356(98)00081-x.

    PubMed 9817107

  • Ramsey SD, Sullivan SD, Kaplan RM, Wood DE, Chiang YP, Wagner JL. Economic analysis of lung volume reduction surgery as part of the National Emphysema Treatment Trial. NETT Research Group. Ann Thorac Surg. 2001 Mar;71(3):995-1002. doi: 10.1016/s0003-4975(00)02283-9.

    PubMed 11269488

  • Ramsey SD, Berry K, Etzioni R, Kaplan RM, Sullivan SD, Wood DE; National Emphysema Treatment Trial Research Group. Cost effectiveness of lung-volume-reduction surgery for patients with severe emphysema. N Engl J Med. 2003 May 22;348(21):2092-102. doi: 10.1056/NEJMsa030448. Epub 2003 May 20.

    PubMed 12759480

  • Diabetes Prevention Program Research Group. Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes. Diabetes Care. 2003 Sep;26(9):2518-23. doi: 10.2337/diacare.26.9.2518.

    PubMed 12941712

  • Kaplan RM. Value judgment in the Oregon Medicaid experiment. Med Care. 1994 Oct;32(10):975-88. doi: 10.1097/00005650-199410000-00001.

    PubMed 7934274

  • Sieber WJ, David KM, Adams JE, Kaplan RM, Ganiats TG. Assessing the impact of migraine on health-related quality of life: An additional use of the quality of well-being scale-self-administered. Headache. 2000 Sep;40(8):662-71. doi: 10.1046/j.1526-4610.2000.040008662.x.

    PubMed 10971663

  • Kaplan RM, Atkins CJ, Timms R. Validity of a quality of well-being scale as an outcome measure in chronic obstructive pulmonary disease. J Chronic Dis. 1984;37(2):85-95. doi: 10.1016/0021-9681(84)90050-x.

    PubMed 6420431

  • Kaplan RM, Anderson JP, Patterson TL, McCutchan JA, Weinrich JD, Heaton RK, Atkinson JH, Thal L, Chandler J, Grant I. Validity of the Quality of Well-Being Scale for persons with human immunodeficiency virus infection. HNRC Group. HIV Neurobehavioral Research Center. Psychosom Med. 1995 Mar-Apr;57(2):138-47. doi: 10.1097/00006842-199503000-00006.

    PubMed 7792372

  • Orenstein DM, Kaplan RM. Measuring the quality of well-being in cystic fibrosis and lung transplantation. The importance of the area under the curve. Chest. 1991 Oct;100(4):1016-8. doi: 10.1378/chest.100.4.1016.

    PubMed 1914549

  • Orenstein DM, Pattishall EN, Nixon PA, Ross EA, Kaplan RM. Quality of well-being before and after antibiotic treatment of pulmonary exacerbation in patients with cystic fibrosis. Chest. 1990 Nov;98(5):1081-4. doi: 10.1378/chest.98.5.1081.

    PubMed 2225948

  • Kaplan RM, Hartwell SL, Wilson DK, Wallace JP. Effects of diet and exercise interventions on control and quality of life in non-insulin-dependent diabetes mellitus. J Gen Intern Med. 1987 Jul-Aug;2(4):220-8. doi: 10.1007/BF02596443.

    PubMed 3302144

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Emphasys Endobronchial Valve (EBV) Device and Procedure in people with Emphysema and Chronic Obstructive Pulmonary Disease, 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: stopped early, 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 was stopped early. Results are not available in the source record.

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?

The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days. 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 NCT00137956, which also lists 25 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.

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