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Procedure

Fissure Completion Surgery for COPD (SAVED-1 Trial)

Boston, MA

N/A

Recruiting

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable with less than 10mg prednisone (or equivalent) daily

Age 40 to 75 years

Must not have

Three or more pneumonia episodes in last year

Three or more COPD exacerbation episodes in the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of the experimental intervention (lung fissure completion with adhesiolysis) to the standard of care (EBVs therapy) in patients with severe emphysema/COPD who have failed bronchoscopic lung volume reduction.

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Who is the study for?

This trial is for people aged 40-75 with severe emphysema/COPD who didn't improve after a specific lung procedure (BLVR). Participants must be stable on low-dose steroids, vaccinated against pneumococcus and influenza, non-smokers for at least 4 months, and still have breathlessness. They should also have the valves from their previous treatment in place.Check my eligibility

What is being tested?

The study tests if performing a surgical technique called fissure completion with pleural adhesiolysis can help patients whose lungs didn't shrink enough after BLVR. This involves using video-assisted surgery to seal parts of the lung and remove scar tissue to potentially improve breathing.See study design

What are the potential side effects?

Possible side effects may include pain at the surgery site, shortness of breath, bleeding or air leaks from the lungs due to surgery complications. There's also a risk of infection post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking less than 10mg of prednisone or its equivalent daily.

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I am between 40 and 75 years old.

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I still feel short of breath after a lung procedure.

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I am willing and able to follow the study's required check-ups and procedures.

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My lung volume reduction was less than 350ml after the procedure.

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I have received the pneumococcus vaccine.

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I have received the flu vaccine.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pneumonia 3 or more times in the past year.

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I have had 3 or more flare-ups of my COPD in the past year.

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I cough up more than 4 tablespoons of mucus daily.

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I have had a lung transplant or surgery to remove lung tissue.

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I have been diagnosed with severe lung damage.

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I have severe heart failure that is not well-controlled.

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My heart and lungs have been healthy in the last 3 months.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of severe adverse events

Prove that inter-lobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fissure completion and adhesiolysis armExperimental Treatment1 Intervention

Patients will undergo a VATS or robotic interlobar lung fissure completion with pleural adhesiolysis. 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.

0 / 14Eligibility criteria met