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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Successful completion of 16 sessions of pulmonary rehabilitation
Moderate to Severe emphysematous destruction of lung parenchyma on chest CT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 year
Awards & highlights
Study Summary
This trial is testing a less risky surgery for COPD to reduce lung volume, improve quality of life and potentially increase survival.
Who is the study for?
This trial is for severe COPD patients with emphysema who experience significant breathlessness and reduced quality of life. They must have completed pulmonary rehabilitation, have specific lung function test results (like FEV1 between 18-45% predicted), and cannot be pregnant or have predominant chronic bronchitis, active heart issues, or lung cancer.Check my eligibility
What is being tested?
The study tests Stereotactic Ablative Radiotherapy (SABR) as a less risky alternative to surgery for reducing lung volume in emphysema patients. It aims to improve survival and quality of life by precisely targeting the diseased parts of the lungs using image guidance.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical radiation therapy risks such as skin irritation at the treatment site, fatigue, shortness of breath, chest pain, coughing up blood or other respiratory symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed 16 sessions of lung rehab.
Select...
My CT scan shows significant damage to my lung tissue.
Select...
I have severe COPD and it greatly affects my daily life due to shortness of breath.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Count of patients with grade 3 or higher adverse events.
Secondary outcome measures
Change from baseline in 6 Minute Walk Test (feet)
Change from baseline in Diffusing Capacity for Carbon Dioxide (% predicted)
Change from baseline in SF 36 Quality of Life Survey Physical Component Summary Score
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic Ablative RadiotherapyExperimental Treatment1 Intervention
Experimental stereotactic ablative radiation treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Ablative Radiotherapy (SABR)
2015
N/A
~190
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,445 Total Patients Enrolled
Varian, a Siemens Healthineers CompanyIndustry Sponsor
30 Previous Clinical Trials
7,263 Total Patients Enrolled
Joseph B Shrager, M.DStudy DirectorStanford University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My main issue is chronic bronchitis with little to no lung damage on a CT scan.I have completed 16 sessions of lung rehab.I cannot complete 16 sessions of lung rehab.I have lung cancer.My CT scan shows significant damage to my lung tissue.Your lung function test shows a certain ratio is too low.Your blood carbon dioxide level is less than 55.Your oxygen levels are higher than 40 when breathing normal air while resting.Your lung function test shows that you have less than 45% or more than 18% of the expected lung capacity.Your lung function tests do not meet the required criteria.I have heart issues that may not allow me to exercise safely.Your lung function test shows a DLCO (lung diffusion capacity) of more than 18% of what is expected.Your lung capacity is too high, as measured by a specific test.I have severe COPD and it greatly affects my daily life due to shortness of breath.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Ablative Radiotherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining vacancies available for this clinical trial?
"Affirmative. Clinicaltrials.gov indicates that this study is actively searching for candidates, having first been posted on February 11th 2013 and most recently edited October 24th 2022. The trial requires 10 test subjects to be recruited from one medical site."
Answered by AI
What is the cap for participants in this experiment?
"Affirmative. According to clinicaltrials.gov, the trial is presently enrolling patients that meet its criteria; this experiment was initially posted on February 11th 2013 and edited most recently on October 24th 2022. The study requires 10 participants from one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
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