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Post by mel on Mar 8, 2014 18:56:01 GMT -5
Hi My Name is Melissa & I am documenting my journey with the Lvrc clinical trial. I am going thru the trial at The University of Texas Medical Center in San Antonio, Tx. I will try to update as I go thru the process.
My Lung Transplant Dr. is running the study and suggested it to me.
11-15-13 I received a letter advising of Appointment.
11-18-13 Went to San Antonio & met with Dr. in charge of Clinical Trial. Received brief exam and did 6 min. walk.
11-19-13 Had tests done: CT, Echo, ECG, PFT & Labs.
11-25-13 Got call from Trial Coordinator that I qualify for Trail.
When I arrived at the Hospital on 11-18 My Husband & I were met by the Clinial Trial Coordinator and she stayed with us thru all of the testing. She expidited the process whenever necessary. This really helped reduce the wait times and made it a more pleseant experience.
Sometime in December, 2013 I was advised that I was in the 'Control Group' and would not be initially receiving the Coils. After partcipating in the trial (12 months) I could be eligible to receive the coils.
12-6-13 Went to San Antonio. Met with Dr., did 6 min walk, had labs and PFT.
2-27-14 " "
At this visit My Dr. was able to tell me that there had been 2 deaths within the total study. Both were pneumonia, 1 in coil gp 1 in control gp. My facility has only placed coils in 2 patients thus far, but I was
told there are others that have qualified.
I will try to update here as I go thru the process.
Thanks
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Post by susanny on Mar 9, 2014 8:42:31 GMT -5
Thanks for doing this, Mel. Do you live near San Antonio? I have a q or two. How many people took part in the total study? Do you know where the other locations are? What happens if you get the coils ... how does this effect your placement on the transplant list? What are your thoughts on this? Thanks. I may have more q's as I think about it. I have a migraine this AM and can't think at all really,  . Take care and good luck to you! Sue |
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Post by jim on Mar 9, 2014 20:47:27 GMT -5
Thanks for sharing your journey thus far Mel, I'm sure a lot of people will find it informative and helpful.
Take care. hug4U
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Post by mel on Mar 10, 2014 9:34:34 GMT -5
Susanny, Here is the link to the clinicl trial information: clinicaltrials.gov/ct2/show/study/nct01608490. It shows the number of facilities & where they are located & how many patients are going to be participating. (I think it was around 300 patients & 30 facilities) The study is ongoing & they are still signing patients up, so there are no final numbers. Participating in the study does not affect my transplant situation. I was also told that you can have the coils removed if it becomes necessary. If you have other questions, let me know & I will try to answer best I can. Thank you Susanny & Jim for your good wishes. |
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Post by aero63 on Mar 10, 2014 11:00:57 GMT -5
Thanks, Mel, for sharing your journey. It is very brave of you.
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Post by yankfrog on Apr 7, 2014 16:37:46 GMT -5
I am being tested on may 7 at Columbia Presbyterian to see if i
am admitted to the coils trial.Ill post the board on developments
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Post by sandy07 on Apr 7, 2014 23:21:09 GMT -5
Mel and yankfrog. I'll be anxiously awaiting further news. I am always overjoyed when someone is brave enough to take on these trials.
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Post by susanny on Apr 8, 2014 21:36:47 GMT -5
Good luck to you, Mel. I will be praying for the best of luck on your testing. It isn't very long from now, is it..... Hope you don't have a long ways to drive to get there. God Bless you.
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Post by deltagirl on Apr 11, 2014 11:56:23 GMT -5
Good luck Mel! I too am very interested to hear how everything goes. Thanks for sharing.  |
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Post by Blossom/Jackie W. on Apr 23, 2014 7:32:51 GMT -5
Looking forward to additional info and updates and.... a big THANK YOU for your willingness to share with others!
Jackie
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Post by yankfrog on Apr 23, 2014 10:24:38 GMT -5
I have the pre-treatment screening schedule:
8:45 AM meet with Dr and coordinator(vital signs and med history)
10:00 Pft
pre+post BD flow-volume loop measurements
Pef,Fev1,FVC
plethysmographic lung volume testing
single-breath DLCO test
arterial blood gas
12:00 questionnaires(quality of life)+dyspnea scale
12:30 6 minute walk test
1:30 CT chest w/o contrast
Lunch
3:00 echocardiogram
4:00 Ekg,chest X ray,Blood panel(CBC,CMP,PT/INR)+cotinine
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Post by susanny on Apr 23, 2014 10:43:08 GMT -5
What a busy day you'll have. I will try to remember to pray for you, otherwise why don't you post a reminder for us. It is a ways away. Thanks for the update!
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Post by fredtx on Apr 28, 2014 20:01:12 GMT -5
Hi my name is Fred. Last Thursday and Friday I was at the University of Texas Health Science Center in San Antonio to complete the testing for the Lung Volume Reduction Coils clinical trial. After the testing I met with the doctor to review the outcome of my tests. I was told that I had met all the criteria that the sponsor for the trial had established. The only concern that was expressed was a blemish that showed up on CT Scan. I told him I had a scan done in 2011 and he requested that I send it to him so that he might be able to tell whether there was some history of this blemish. I sent the CD this morning via FEDEX for his review.
While I am hopeful that I will qualify for trial but am not confidant since he indicated that he thought it was 50-50 as to whether I will make it. My concern is primarily due to my emphysema being homogenous. But I'll keep my fingers crossed. I will post the results when I get the word.
Fred
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Post by sandy07 on Apr 29, 2014 22:21:33 GMT -5
Thanks for letting us know Fred. We'll be waiting with you.
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Post by fredtx on May 9, 2014 19:02:32 GMT -5
Late this afternoon I received a phone call from the LVRC Study Coordinator at the University of Texas Medical Center saying that not only did I qualify for the trial, the result of the randomized computer selection put me in the Coil Treatment Group for the procedure. I will be provided with a list of dates for the procedure according to the surgeon and sponsor company(PneumRx) availability. Hopefully, that will be sometime in the next couple of weeks.
I was a participant of the US FDA clinical trial for Spiriva, and that was very gratifying to me to be in a trial which is being used by many people like us. Now I will be given the opportunity to demonstrate whether this will be equally beneficial.
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Post by yankfrog on May 10, 2014 11:01:41 GMT -5
I flunked my PFT for the trials due to residual volume.I was given a different
test than the standard PFT described as european coal miners test. if you flunk,
you are sent home at that point so the day can be short.
Good luck Fredtx, my test was in NY
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Post by Blossom/Jackie W. on May 10, 2014 11:04:46 GMT -5
Fred; I am SOOOOOOO excited for you! Especially since your Emphysema is distributed throughout your lungs (not that it's good; but it's good that it can/will still be done) and not just in certain areas. That, in itself means hope for a lot of people! (Hiope you know what I was meaning or trying to say)
Good Luck dear and please keep us updated!
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Post by sandy07 on May 10, 2014 23:28:51 GMT -5
Fred...we'll be watching and waiting.
yankfrog....sorry it didn't work out. You never know, there might be something else down the road.
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Post by jim on May 12, 2014 21:03:57 GMT -5
Thank you Yankfrog and Fred for sharing your experiences. I sorry it didn't work out for you Yankfrog and I'm hoping that there is something coming up soon that can help you. I'm happy for you Fred, and hoping all goes well for you.
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Post by John on May 14, 2014 5:43:15 GMT -5
I want to thank both of you for sharing . thumbsupde1 hug4U
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Post by Blossom/Jackie W. on May 14, 2014 7:13:06 GMT -5
Dang it all Yankfrog. You got to the alter and found out the bride didn't show! I'm sorry to hear it. Here's hoping something else will come down the pike.
How about you Mel? Any news for us?
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Post by Mr. Wizard on May 15, 2014 15:46:15 GMT -5
I have applications in for the trial in Philly and NYC. Hope it works out. I'm also trying to see if any countries in Europe/Asia perform the procedure as a patient, not as part of a clinical. As a retired Drug researcher, I know that the FDA and the politic ans will drag their feet on this, even if it works wonders. Since COPD is a disease frequently of Seniors, Medicare/Medicade will be responsible for a lot of procedures!!
Good luck to all. I hope things work out for everyone. I check this site daily.
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Post by sandy07 on May 15, 2014 22:50:54 GMT -5
Good Luck Mr. Wizard.
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Post by yankfrog on May 16, 2014 9:29:43 GMT -5
In the coil trials they want to show significant improvement to pass the FDA.Thus
RV greater than 225%,for LVRS it is much lower-150% or greater.
I believe you can get the coils in France and Germany.I have a friend who did this.
3 overseas trips and the proceedure cost roughly 60k-no medicare.He does feel
alot better.
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Post by Blossom/Jackie W. on May 18, 2014 14:58:18 GMT -5
Good Luck Mr Wizard!!!
Yankfrog..... You're showing the RV (residual volume) numbers differently than what I'm accunstomed to seeing. Darn near too good or maybe; I'm misinterpreting or reading wrong. Very possible (seeing/reading wrong - for me to be doing it right now)
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Post by fredtx on May 22, 2014 13:37:32 GMT -5
Late this afternoon I received a phone call from the LVRC Study Coordinator at the University of Texas Medical Center saying that not only did I qualify for the trial, the result of the randomized computer selection put me in the Coil Treatment Group for the procedure. I will be provided with a list of dates for the procedure according to the surgeon and sponsor company(PneumRx) availability. Hopefully, that will be sometime in the next couple of weeks. I was a participant of the US FDA clinical trial for Spiriva, and that was very gratifying to me to be in a trial which is being used by many people like us. Now I will be given the opportunity to demonstrate whether this will be equally beneficial. |
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Post by fredtx on May 22, 2014 13:52:32 GMT -5
I received a telephone call from the LVRC Study Coordinator at the University of Texas Health Science Center telling me that my first bronchoscopy procedure is scheduled for June 13. I have been getting more and more anxious waiting to hear that information. While I am hopeful for the best result possible, if it is not, at least I know I have done everything I could to improve my QOL.
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Post by Blossom/Jackie W. on May 23, 2014 15:15:19 GMT -5
You did GREAT Fred! As for the broncho; just relax. (I know; easier said than done) Nothing to be gained by stressing about it. The test isn't that bad but I'm sure you're thinking more along the lines of the outcome. Well; I think I can say speaking from us here at least.... WE GOT YOUR BACK! Special prayer heading your way.
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Post by Mr. Wizard on May 23, 2014 20:27:43 GMT -5
Like Yankfrog, I found out that my residual volume was to great, My lungs weren't damaged enough to be included in the US trial. To get approval for the coils , the FDA want to see increased survival time, not improved quality of life and the best way to increase survival time is to start with very damaged tissue so that a small improvident correlates to a large Percentage improvement, even if the gain is small.
I'm continuing on my plan "B", finding facilities overseas that will do the procedure as a private patient, not part of a US trial
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Post by fredtx on Jun 16, 2014 13:11:44 GMT -5
Last Friday, the 13th, turned out to be a lucky day for me. I had the LVRC procedure done in San Antonio at the University of Texas Medical Center. It was done on the lower lobe of my left lung and the doctor placed 14 coils in that area. The procedure took 1.5 hours and after getting out of recovery they did a chest x-ray. I then was put in the hospital for observation. In the morning they did another x-ray to be sure everything was ok and once the doctor examined it I was released to go home.
By Saturday evening I was starting to feel pretty good with Sunday being even better. Only issue was discharging of some blood which continues today. This is very normal for Bronchoscopy procedures. It will subside after a few days.
I feel better and only get SOB after exertion but I have noticed that my rebound time has improved. Went to Pulmonary rehab this morning and my exercises seemed to be easier than last week before the procedure.
The healing and recovery will take some time and next month I will return to the hospital to repeat the tests that I took to qualify for this trial so that it may be compared to the initial results. I am very pleased with the procedure and am looking forward to the right lung procedure sometime in the next four months. After just two days my progress has exceeded my expectations.
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