Spiration Valve System for Emphysema

Recruiting at 14 trial locations

Overseen By Courtney Inge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Olympus Corporation of the Americas

Disqualifiers: Inappropriate for SVS, Incomplete data, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Initial implantation

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the long-term safety and effectiveness of the Spiration Valve System, a treatment for individuals with severe emphysema. Emphysema is a lung condition that impairs breathing due to damage in the air sacs. The trial seeks participants who experience shortness of breath and hyperinflation (excess air trapped in the lungs) associated with severe emphysema and low collateral ventilation (reduced airflow between lung areas). Participants must understand the trial and agree to join by signing an informed consent form. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for emphysema.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Spiration Valve System?

Research has shown that the Spiration Valve System (SVS) is generally safe for treating severe emphysema. Studies recommend this system based on safety and effectiveness data from various international research. Patients who received the SVS were monitored for up to 12 months, and the treatment was well-tolerated.

However, some risks require consideration. The SVS should not be used in individuals with active asthma, bronchitis, or significant bronchiectasis, a condition where the airways are scarred and widened. These existing conditions might lead to complications.

Overall, the available data suggests the Spiration Valve System is safe for most people with severe emphysema, but discussing any specific health concerns with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Spiration Valve System is unique because it offers a minimally invasive approach to managing severe emphysema, a form of chronic obstructive pulmonary disease (COPD). Unlike traditional treatments such as medication and surgery, this system uses a tiny valve inserted into the airways to redirect airflow and reduce lung hyperinflation. Researchers are excited about this treatment because it can improve breathing and quality of life without the need for major surgery, offering a significant advancement in the management of emphysema.

What evidence suggests that the Spiration Valve System is effective for severe emphysema?

Research has shown that the Spiration Valve System (SVS) effectively treats severe emphysema. Studies have found that patients using SVS experience noticeable and lasting improvements in lung function and breathing. Those treated with SVS reported a better quality of life, as they could breathe more easily and felt more comfortable. The evidence supports that SVS offers real, long-term benefits for individuals with emphysema. ^{1 5 6 7 8}

Who Is on the Research Team?

Gerard Criner, MD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

Inclusion Criteria

Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.

Subjects must understand and voluntarily sign an informed consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Spiration Valve System (SVS) for the treatment of severe emphysema

Initial implantation

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Regular visits at 6, 12, 24, and 36 months

Long-term monitoring

Continued assessment of safety and effectiveness of the Spiration Valve System

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Spiration Valve System

Who Is Running the Clinical Trial?

Olympus Corporation of the Americas

Lead Sponsor

Trials

22

Recruited

2,500+

Spiration, Inc.

Lead Sponsor

Trials

12

Recruited

1,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37948704/

Sustained Clinical Benefits of Spiration Valve System in ... SVS treatment resulted in statistically significant and clinically meaningful durable improvements in lung function, respiratory symptoms, and QOL.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01812447

Evaluation of the Spiration® Valve System for Emphysema ... EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the safety and long-term effectiveness of the Spiration Valve System ...

3. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202306-520OC

Sustained Clinical Benefits of Spiration Valve System in ... SVS treatment resulted in statistically significant and clinically meaningful durable improvements in lung function, respiratory symptoms, and QOL.

4. medical.olympusamerica.com medical.olympusamerica.com/articles/study-results-show-sustained-clinical-benefits-spiration-valve-system-24-months

Study results show the sustained clinical benefits of Spiration ... Patients treated with the Spiration Valve System experienced a significant improvement in lung function, respiratory symptoms and quality-of-life scores at 24 ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180007B.pdf

summary of safety and effectiveness data (ssed) The results confirm that the Spiration Valve System can be adequately sterilized using the new larger eight (8) pallet chamber to a ...

6. medical.olympusamerica.com medical.olympusamerica.com/products/spiration-valve-system-treatment-severe-emphysema

Spiration Valve System for Treatment of Severe Emphysema Based on safety and efficacy data from multiple international clinical studies, BLVR achieved using endobronchial valves is now recommended by numerous ...

7. spirationvalve.com spirationvalve.com/potential-risks-complications

Potential Risks & Complications | Olympus SVS - Spiration Valve The Spiration Valve System should not be used for patients who have active asthma, bronchitis or clinically significant bronchiectasis.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10848907/

Sustained Clinical Benefits of Spiration Valve System in ... Follow-up of patients with emphysema treated with endobronchial valves is limited to 3–12 months after treatment in prior reports.