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Procedure
Bronchial Rheoplasty for Chronic Bronchitis (RheSolve Trial)
N/A
Waitlist Available
Led By Arschang Valipour, MD
Research Sponsored by Gala Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is at least 35 years of age.
Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
RheSolve Trial Summary
This trial will assess the safety and effectiveness of a new treatment for chronic bronchitis called Bronchial Rheoplasty. A total of 270 patients will be randomized and followed for 2 years at up to 40 study centers.
Who is the study for?
Adults over 35 with moderate to severe chronic bronchitis, a history of smoking, and specific scores on respiratory health questionnaires. They must be on stable medication for at least 8 weeks and able to walk more than 225 meters. Excluded are those with emphysema, asthma, certain heart conditions or devices that can't be turned off during procedures, unresolved lung cancer, recent smokers or other serious medical issues.Check my eligibility
What is being tested?
The trial is testing the RheOx Bronchial Rheoplasty System against a sham procedure to see if it's safe and effective in treating symptoms of chronic bronchitis in COPD patients. It's randomized and double-blind meaning neither the participants nor the researchers know who receives which treatment until after the results are collected.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications from bronchoscopy such as sore throat, coughing or infection; reactions to anesthesia; and any specific risks associated with manipulating airways during rheoplasty like tissue damage.
RheSolve Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 35 years old or older.
Select...
I have had a cough with mucus for 3 months each year for 2 years, and other causes have been ruled out.
Select...
I have smoked the equivalent of 10 packs of cigarettes a year.
RheSolve Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
COPD Assessment Test (CAT) Score
Secondary outcome measures
COPD Exacerbations
Cough Frequency
Distal Airway Volume
+1 moreRheSolve Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RheOx TreatmentExperimental Treatment1 Intervention
Group II: Sham ProcedurePlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Gala Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
149 Total Patients Enrolled
4 Trials studying Chronic Bronchitis
149 Patients Enrolled for Chronic Bronchitis
Arschang Valipour, MDPrincipal InvestigatorKarl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
3 Previous Clinical Trials
162 Total Patients Enrolled
Frank Sciurba, MDPrincipal InvestigatorUPMC; Division of Pulmonary and Critical Care Medicine
4 Previous Clinical Trials
2,501 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung spot that might need treatment during the study.I need more than 10 mg of oral steroids daily for my condition.I am 35 years old or older.I have an ongoing lung infection that hasn't healed.You have a CAT score of 10 or higher.I have been on long-term lung medication or tried it in the past year without improvement.I cannot walk more than 225 meters in 6 minutes.I do not have any serious health conditions that could affect my safety or the study results.I have been diagnosed with asthma.Your lung function is at least 30% of what is expected for someone of your age and size after using a bronchodilator.I have severe lung damage that affects my cough and mucus production.My CT scan shows I have significant emphysema.I have had lung surgery or procedures but no lung resection.I have had a cough with mucus for 3 months each year for 2 years, and other causes have been ruled out.Your lung function test shows a certain ratio is too low.I have been diagnosed with severe pulmonary hypertension.I had a serious heart rhythm problem in the last 2 years but it's treated now.Your SGRQ score is 25 or higher.I have smoked the equivalent of 10 packs of cigarettes a year.My lung cancer has not been cured.You have used any kind of smoking or vaping, including tobacco and marijuana, in the last 6 months.I have severe acid reflux that isn't managed by my current treatment.Your answers to the first two questions add up to at least 7 points, or they add up to 6 points and your total score is more than 20 points.
Research Study Groups:
This trial has the following groups:- Group 1: RheOx Treatment
- Group 2: Sham Procedure
Awards:
This trial has 0 awards, including: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.
Chronic Bronchitis Patient Testimony for trial: Trial Name: NCT04677465 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total headcount of participants in this clinical trial?
"Yes, the clinicaltrials.gov page states that this medical trial is actively recruiting participants at present. This study was initially posted on April 7th 2021 and most recently updated on November 9th 2022; it seeks to enroll 270 individuals across 34 sites."
Answered by AI
How many healthcare facilities are actively conducting this research project?
"University of Mississippi in Jackson, Lahey Hospital and Medical Center in Burlington, and Mayo Clinic in Rochester are some establishments hosting this trial. Altogether there are 34 other sites participating as well."
Answered by AI
Are there any openings to participate in this trial at present?
"As indicated by the information on clinicaltrials.gov, this medical research endeavour is presently looking for participants. It was originally available to view on April 7th 2021 and underwent its last update in November 9th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
OSF Saint Francis Medical Center
Why did patients apply to this trial?
I have severe copd & I want to make my quality of life better & prolong my life as long as possible!
PatientReceived 2+ prior treatments
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