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Procedure
Fissure Completion Surgery for COPD (SAVED-1 Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
SAVED-1 Trial 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.
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.
SAVED-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
SAVED-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
SAVED-1 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.
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,010,406 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You still have endobronchial valves in your lungs.I have had pneumonia 3 or more times in the past year.I have had 3 or more flare-ups of my COPD in the past year.I am taking less than 10mg of prednisone or its equivalent daily.I am between 40 and 75 years old.I cough up more than 4 tablespoons of mucus daily.I have had a lung transplant or surgery to remove lung tissue.I have not had a heart attack in the last 6 months.I still feel short of breath after a lung procedure.Your resting heart rate is very slow, or you have specific types of abnormal heart rhythms.Your carbon dioxide level is too high when breathing regular air.I am willing and able to follow the study's required check-ups and procedures.I cannot stop taking my blood thinners safely for a week.I have been diagnosed with severe lung damage.I have severe heart failure that is not well-controlled.My lung volume reduction was less than 350ml after the procedure.I have received the pneumococcus vaccine.Your oxygen level is very low when breathing normally.My heart and lungs have been healthy in the last 3 months.My heart's pumping ability is below 40%.I have received the flu vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Fissure completion and adhesiolysis arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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