Wednesday, June 29, 2016
COPD (Chronic Obstructive Pulmonary Disease)
IBV Valve Clinical Trial
In May 2010 I participated in this clinical trial. After six months of tests, office visits and perserverance; I found in December I was in the control group and did not get the valves. My doctor tells me that since winter is cold/flu season he would be looking at April 2011 for me to get the valves. At my January 2011 appointment; my doctor tells me there is a moratorium on this procedure and I will not be able to have it done. I explained that I needed that in writing; and he promised to send out a letter to me immediately stating these facts.
After over a month of not hearing from him; I call him back to see what the tie up is. He said that he is going to get the letter from the FDA and have it sent to me. That was over a month ago and still no word. When I speak with those at Spiration and the FDA; they tell me there has not been, nor is there now any moratorium on this procedure. What is going on here? I understood that I would be able to have this procedure done after the six month trial if I did not get them at the onset. Now I find I did not get the valves; and I am chasing a ghost. That ghost is the promise of a medical device that would be beneficial to my life.
Where does this leave me? I can not get any more word from my doctor; all he says is that he is waiting on word from the device maker and the FDA. I know he is blowing smoke; I just do not know why...
Thank you for visiting NetWellness. Although it is not possible for us to help you directly with your question, you may find the appropriate contact in your informed consent papers. We are attaching information about informed consent to assist you.