RENEW Clinical Trial – Evaluating a Treatment for Patients with Emphysema
More than three million Americans suffer from severe emphysema, a form of COPD (Chronic Obstructive Pulmonary Disease). This chronic, debilitating disease causes irreversible damage to delicate lung tissue, leading to shortness of breath and reduced capacity to manage activities of daily living, leading to diminished quality of life.
The Palo Alto Medical Foundation is collaborating with El Camino Hospital and Fogarty Clinical Research Inc. to conduct a clinical trial to evaluate the investigational use of the RePneu® (pronounced ‘RENEW’) Lung Volume Reduction Coil (LVRC) for patients experiencing symptoms of emphysema.
Together the Palo Alto Medical Foundation Research Institute and Fogarty Clinical Research Inc. aim to enroll 15 to 20 participants within two years. To do so they will have to screen hundreds of potential participants. Eligibility criteria limit participants to those:
- Older than 35 years of age
- Diagnosed with emphysema
- Experiencing increasing difficulty with simple daily tasks
- Stopped smoking for at least eight weeks
- Completion of pulmonary rehabilitation program within six months and/or on maintenance program
How does the RePneu LVRC work?
The LVRC is implanted in the airways of the lung and works by compressing the diseased lung tissue, creating more room for healthier areas of the lung to expand and function. It is also designed to help restore the lung’s natural elasticity and prevent airway collapse, making it easier for patients to breathe. More details are presented in the informational brochure created by PneumRx, Inc.
The principal investigator for this clinical trial is Ganesh Krishna, M.D., expert in pulmonary disease and critical care at the Palo Alto Medical Foundation. Juliet Wilson, of the Fogarty Clinical Research, Inc., is the study coordinator.
Outreach to physicians and people with emphysema is underway, with the aim of drawing potential participants to 30 sites in the United States and Europe for evaluation. Only four of the 30 clinical trial sites are in the western region of the U.S. The collaborative Palo Alto Medical Foundation and Fogarty Clinical Research trial is the only one in the San Francisco Bay Area.
Enrollment and more information
For enrollment information visit the Fogarty Clinical Research Inc. website or call the Study Coordinator Juliet Wilson at 650-962-4463.
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