UCLA researchers seek adults with severe chronic obstructive pulmonary disease (COPD) for a study assessing the effectiveness of an experimental device coupled with current medical therapy in helping patients to breathe easier.
COPD refers to two conditions, chronic bronchitis and emphysema, which damage the lungs making it difficult to breath. COPD causes the air sacs in the lungs to lose elasticity and the ability to effectively fill-up and exhale air.
The study device, implanted during a minimally-invasive procedure, is called the ROX Anastomotic Coupler System and connects to a vein in an artery in the pelvic area creating a connection that allows some of the blood to flow directly from the artery into the vein. This "short cut" allows more oxygen to be circulated through the lungs and other parts of the body, which may make it easier to breathe and walk farther.
"We hope that this novel device may provide another option to help relieve symptoms for patients with severe COPD," said Dr. Christopher Cooper, principal investigator and professor of medicine and physiology at the David Geffen School of Medicine at UCLA. "Currently there is no cure for this progressive disease and treatment options are limited."
To qualify for the 12-month study, volunteers must have severe COPD. Participants will be assigned by random (similar to flipping a coin) to receive either the experimental device in addition to medical therapy or continue treatment with medical therapy alone.
Volunteers will perform several pulmonary function tests and be given a heart echocardiogram, right heart catheterization procedure, vascular ultrasound and computer tomography imaging (CT) of the pelvic area. The device procedure requires an overnight hospital stay.
Side effects range from mild such as fever to more severe such as infection and can occur from device placement and use. All participants will be closely monitored during the study.
The study is funded by ROX Medical, manufacturers of the Anastomotic Coupler System. Dr. Cooper has received an honorarium for serving on an advisory board for the company.
For more information about the study, please contact John Wheeler at (310) 825-2616.
The challenge is accepting submissions through May 1, 2019