Endobronchial valves placement for Emphysema

Phase-Based Estimates
1
Effectiveness
1
Safety
Beth Israel Deaconess Medical Center, Boston, MA
Emphysema+2 More
Endobronchial valves placement - Device
Eligibility
18+
All Sexes
Eligible conditions
Emphysema

Study Summary

Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema

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Eligible Conditions

  • Emphysema
  • Focal Emphysema
  • Emphysema or COPD
  • Pulmonary Emphysema

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Endobronchial valves placement will improve 4 primary outcomes and 3 secondary outcomes in patients with Emphysema. Measurement will happen over the course of Through study completion, an average of 2 years.

2 years
Percentage of patients to achieve target lung volume reduction
Percentage of patients with quality of life improvement
Percentage of patients with significant changes in pulmonary function testing
Prove that inter-lobar fissures can be completed to at least 95% via VATS in severe emphysema patients
Prove that inter-lobar fissures can be completed to at least 95% via robotic thoracic surgery or VATS in severe emphysema patients
Prove that patients consented for the procedure will ultimately undergo the intervention
Year 2
Incidence of severe adverse events

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Intervention group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Endobronchial Valves Placement is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention groupCOPD patients with severe emphysema and incomplete lobar fissures will undergo video-assisted thoracic surgery fissure completion and valves placement. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.
Crossover groupSubjects allocated to the medical management group will be offered to crossover after the 3 months follow-up period. The same procedure as in the intervention group will be performed. Follow-up after surgery will be the same as in the intervention group.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
A. M.
Adnan Majid, MD
Beth Israel Deaconess Medical Center

Closest Location

Beth Israel Deaconess Medical Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 40 to 75 years.
Stable with less than 10mg prednisone (or equivalent) daily.
You are not smoking at the time of screening show original
Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
Current pneumococcus vaccination.
Current influenza vaccination.
You are willing and able to complete the study follow-up assessments and procedures. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for emphysema?

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Inhalation options have emerged as effective treatments with minimal side effects for the management of emphysema. Appropriate use of inhaled bronchodilators such as β-agonists such as salbutamol or corticosteroids such as budesonide are highly effective and may be used concurrently. Inhaled monotherapy with long-acting salbutamol or a corticosteroid, such as budesonide, is efficacious and well tolerated in the long term.

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Can emphysema be cured?

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While emphysema is not curable it can be treated. The cornerstone of treatment is smoking cessation. In fact, the benefits of smoking cessation are so strong that, as in the case of diabetes, most patients will be advised to stop before they start getting the disease. The other mainstay of prevention is quitting. This advice would be easier if emphysema could be cured, and then smoking cessation would be easy, but this looks unlikely.

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What are the signs of emphysema?

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The main signs of emphysema are unexplained weight loss, breathlessness and wheezing due to asthma. These signs are usually nonspecific, but may be the most likely presenting features of emphysema.

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What is emphysema?

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Emphysema is a disease where small pockets form in the lungs. These pockets are filled with pus and have a strong stinky smell. The puffy look of the person's chest may give the disease a caddish sense. The disease is not a life-threatening illness. It is however debilitating as it can cause severe breathlessness and difficulty breathing and coughing. A related condition is a collapsed lung. These conditions will cause a person constant and bad breath. They are also quite unpleasant. Lung disease is often diagnosed at an early stage and there is an urgent need for diagnostic tests.

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How many people get emphysema a year in the United States?

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Rates of emphysema vary widely by age and according to what is being measured. Since the prevalence of emphysema in North America is estimated to be 1-2% for men and 1% for women, we should expect at least about 10-20 million people to have emphysema a year, given the known prevalence of emphysema in North America and the average longevity that prevails in the United States (80 years).

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What causes emphysema?

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Emphysema is known to be caused by some genetic mutations and toxins. A variety of factors, such as cigarette smoking and air pollution, is found in the asthma population, but the exact cause is unknown. The mechanism is unknown, but it is believed that the cause has a genetic component. Smoking or excessive alcohol use appears to play a role through a process called oxidative stress.\n

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What is the primary cause of emphysema?

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Several pathophysiological pathways are involved in the development of emphysema: gas trapping, chronic inflammation, and epithelial cell injury. However, it is still unknown which of these pathways underlie emphysema in patients with alpha-1-antitrypsin deficiency.

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What is endobronchial valves placement?

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If you can see one valve on CT, you can see two valves on HRCT. It is not a single organ. There is not enough data to determine which is the “right” valve depending if one or two are seen on a CT or HRCT. There are two types of valves on the left bronchial tree that we can see on CT/HRCT: the subsegmental valve and the segmental valve. The former is a bundle of lung tissue from which the right mainstem bronchus arises. The segment of this bundle is usually dilated and thickened.

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Is endobronchial valves placement safe for people?

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It is difficult to determine the optimal treatment for endobronchial valve disruption in the thoracic surgery literature, as the majority of studies are retrospective. In our experience, this procedure with fluoroscopic visualization of the endobronchial valve is safe, although a certain degree of morbidity can be anticipated. There seems to be a slight trend toward prolonged ventilatory support in our series. In this retrospective study, the risk of mortality and reintervention is very low.

Unverified Answer

Is endobronchial valves placement typically used in combination with any other treatments?

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The study shows that the use of endobronchial valves for the treatment of severe emphysema (Sx) appears to be successful when paired with an optimal treatment with respect to age of patient, gender, and disease stage. This may be the most ideal patient group to use endobronchial valves in combination with an optimal treatment in most cases.

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Have there been any new discoveries for treating emphysema?

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Over the last 20 years, many advances in therapies have been made for emphysema. There will be times when the medical community will be able to add many more treatments to the available treatment options. As physicians become more knowledgeable of recent advances in understanding emphysema pathophysiology and treatment, their knowledge will keep growing and most patients will eventually be candidates for the most recent therapies\n

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What is the latest research for emphysema?

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There are no new findings to report on today. The literature search shows that the current literature shows only that we still need to know more about all the factors involved; and we must find ways to communicate our findings to those who can use them to inform healthy people, particularly women, about how to live so as to limit the risk of premature death. Emphysema is not likely to be a 'top priority' in the next few decades as was claimed on television recently. Current estimates for all smokers suggest that it will be a very distant future. But, maybe it could become the number one problem to hit if we don't act very quickly as we should.

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See if you qualify for this trial
Get access to this novel treatment for Emphysema by sharing your contact details with the study coordinator.