Related Links:
For additional information about the WALK Trial, please refer to the following links.
- The WALK Trial is registered at clinicaltrials.gov
What is a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions. Clinical studies like the WALK™ Trial determine whether experimental treatments are safe and effective under controlled environments.
What is the purpose of the ROX WALK™ Trial?
The WALK™ clinical trial tests the effectiveness of the ROX Anastomotic Coupler in patients suffering from severe Chronic Obstructive Pulmonary Disease (COPD). The coupler allows oxygen rich blood to pass from an artery to a vein in the pelvic region and is designed to reduce hypoxemia and COPD symptoms, possibly leading to greater exercise tolerance and or an improved quality of life.
Are clinical trials safe?
All clinical trials in the United States must be approved by the U.S. Food and Drug Administration and adhere to strict regulations protecting the rights of participants. To help ensure the relative safety and effectiveness of the treatment, each trial must undergo preclinical testing before large-scale testing in people may begin.
What is informed consent?
Participants must sign an "informed consent" document before joining the study indicating they understand that the trial is research. The document ensures that potential participants have the information necessary to make an informed decision about the level of risk and commitment to study procedures they are willing to accept before they enter the trial.
What are the potential benefits?
Potential benefits include getting actively involved in your health care, gaining access to potentially new research treatments, expert medical care for the condition being studied and helping others by contributing to medical research.
What are the potential risks?
Potential risks include unexpected side effects or adverse reactions resulting from the treatment. The new therapy may not be as effective as previous research indicated and the study may require more time and effort than a standard treatment.
Can I leave a clinical trial after it has begun?
Patients enrolling into a clinical trial are asked to commit to following the study procedures. However, your participation in a clinical trial is always voluntary and you may leave it at any time.
