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RheOx Device for Chronic Bronchitis (Gala_EFS Trial)
Gala_EFS Trial Summary
This trial is testing a new medical device to see if it is safe and helpful for people with chronic bronchitis.
Gala_EFS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGala_EFS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Gala_EFS Trial Design
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Who is running the clinical trial?
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- You have used any form of smoking, including tobacco, marijuana, e-cigarettes, or vaping, in the past 6 months.I've had a lung infection or mild/moderate COPD flare-up recently.I have had chemotherapy in the last 6 months or will have it during the study.I have had chronic bronchitis for at least two years.I have had surgery on my lungs or a procedure that didn't involve cutting.My CT scan shows severe bronchiectasis is the main cause of my symptoms.I have serious health issues like heart failure, recent heart attack, kidney or liver disease, stroke in the last 6 months, uncontrolled diabetes or blood pressure, or autoimmune disease.I have had lung cancer that hasn't fully resolved in the past 5 years.I cannot stop my blood thinners for a week before a lung exam.I have had at least one severe COPD flare-up in the last year.I am taking more than 10 mg of prednisolone or prednisone daily.I have severe acid reflux that isn't managed by my current treatment.My lung function test shows 30-80% of the expected result.I have a lung spot that might need treatment during the study.I have severe pulmonary hypertension.I have had heart rhythm problems in the last two years.I have a serious heart muscle condition.You have a SGRQ score of 25 or higher and a CAT score of 10 or higher.Your answers to the first two questions in the CAT questionnaire must add up to at least 7 points. If they add up to 6 points and your total CAT score is over 20 points, you may still be able to join the study.I cannot walk more than 100 meters in 6 minutes.I have smoked at least 10 pack-years.I have large blisters on my lung scan.
- Group 1: RheOx Treatment
- 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
How many North American hospitals are currently conducting this research?
"This research project is operating out of Temple University School of Medicine in Philadelphia, Pennsylvania, University of Pittsburgh Medical Center in Pittsburgh, Iowa and the University of Iowa in Iowa City. Additionally, it has been extended to encompass 8 additional locations."
Are there any opportunities to join this clinical experiment at present?
"The clinicaltrials.gov website conveys that this investigation is no longer recruiting participants after last being updated on April 11th 2022; however, 80 separate trials are still open to enrolment at present time. The trial was posted initially on July 6 2018."
What would constitute a successful result from this trial?
"This clinical trial has been designed to measure the safety of a particular intervention over 12 months. Secondary objectives include tracking alterations in St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) scores at 6 and 12 month intervals, respectively."
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