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Fissure Completion Surgery for COPD (SAVED-1 Trial)
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.
SAVED-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAVED-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SAVED-1 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Fissure completion and adhesiolysis arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any stipulations for participation in this trial?
"This medical experiment is enrolling 20 patients aged 40-75 with emphysema who must meet the following conditions: taking no more than 10mg of prednisone daily, not having smoked in four months and willing to abstain from smoking during the trial duration, pneumococcal vaccination up to date, current flu shot, pre-specified lung volume reduction post BLVR <350ml., MMRC score >2 after BLVR procedure., Endobronchial valves still present,, capacity for study visits/procedures."
What is the current enrollment of participants in this medical trial?
"Affirmative. Clinicaltrials.gov exhibits that this clinical trial, which commenced on May 24th 2022, is presently looking for participants. Approximately 20 patients need to be enrolled from 1 medical centre."
Are there any openings for volunteers to join this research project?
"Affirmative. Clinicaltrials.gov contains data which indicates that this study is presently in the process of recruiting participants, with 20 individuals sought from a single clinical trial site since its original posting on May 24th 2022 and subsequent update on June 10th 2022."
Does the trial's criteria include individuals of advanced age?
"This clinical trial will only accept patients between 40 and 75 years of age. For those younger than 18 or older than 65, there are 30 ancillary studies accepting participants."
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