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Post by zar on Jan 11, 2011 12:51:43 GMT -5
I have been asked if I would like to take part in a new trial,here is parts of the fifteen page letter.
A prototype has, with the permission of the MHRA,been used in three (3) of our patients without ill affects.A "first in man" study using an earlier model of the Portaero Pneumostoma System was tested in Europe and Australia (Helen from the Netherlands may know about this?)The study included 15 patients as of 19 August 2009 and five(5) of those were Royal Bromptom Hospital patients (the hospital which I am under).
The early clinical study is on going but stopped accepting new patients.Of our five(5) patients,one chose to leave the study early and let the pneumostoma close because the Disposable Tube device was not staying in the pneumostoma.
The device was redesigned to create a longer tract and improve the fit of the Disposable Tube in the pnumostoma.
It is the redesigned device that will be used in this study.
The Sponsor of this study=Portaero,Inc.,(Cupertino,California USA).
The study will before +- 8 months including the 6 months following surgery.Your participation will involve at least (8)visits to the clinic including the actual surgery and follow up tests.
Surgery:.....A catheter will be placed through the chest wall between the lung and the chest wall to draw off any air that has leaked into this space.This will be left in position overnight or until the drainage is complete.Once the surgery is finished, you will be monitored closely in the recovery unit before returning to the ward.As soon as you are able to drink liquids you will be given a daily dose of predisolone( or similar drug). You will continue to take this drug as instructed by your study doctor through your recovery period.This drug will help reduce inflammation/discomfort and response to inflammation around your pneumostoma as a result of the procedure.
You will stay in hospital for1-2 weeks before being discharge home.
You will go home with the Portaero Access Tube in place and you will be given a course of antibiotics to reduce the risk of infections.You will also be given a supply of Hold Down components(this is a accessory device).You will change this Hold Down component to help absorb mucous material that may come out of your pneumostoma.Study staff will instruct you to monitor you pneumostoma for sounds,fit,and health of your pneumostoma.
Insertion of Disposable Tube Device.
When the channel has healed (21 t0 35 days after your procedure),you will return to the hospital and the Access Tube will be removed and replaced with a Disposable Tube.The device will allow trapped air in your lungs to escape.You will need to care for your pneumostoma and use the Disposable Tube at home.Your study doctor will show you how to replace the device and will explain to you how often you will need to replace the device(varying from twice a day,once a day, or every two days).The study staff will be available for advice and support when you are learning how to take care of your pneumostoma.
Your pneumostoma will be evaluated at different times during the study to assess the health of the pneumostoma and to determine if air continues to move out of your pneumostoma.
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Post by Blossom/Jackie W. on Jan 11, 2011 13:11:37 GMT -5
Wow Zar! That sounds really interesting! So...... any idea how long it lasts or what's considered a measurable positive outcome, or, or.....
Obviously you'll be talking with them about it soon? Are you looking at participating?
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Post by susanny on Jan 11, 2011 22:50:46 GMT -5
I looked up pneumostoma: www.faqs.org/patents/app/20090205641 Is this what you are talking about? It sounds interesting, but very complex to me. It will take diligence to take care of each day. I don't know as I would/could do it, but will be interested to hear what they have to say to you about it when you have your face-to-face meeting about it. |
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Post by zar on Jan 13, 2011 14:15:17 GMT -5
www.anzctr.org.au/trial_view.aspx?ACTRN=126100001900Jackie, For me it would be 6 months as I have already done rehab,maybe a extra week for tests i. e ECG,Xray,ECHO,PTF,and 6 MWT etc. Strangely enough in the fifteen page info sheet there is nothing about what their goal is,which seems strange to me,but at the site that I have posted at the top here it says they are hoping for or up to 12% increase. I like most of us am no doctor,but if you started a study in August 2009.Why after 18 month there are no results at all. Surely they should now if there has been any improvements?,and that study is on going ?.Perhaps they are fitting the patients in that study with the redesigned Disposable Tube. Then as for the surgery,it wont be like having the stents or coils,going in the morning coming out in the afternoon or next day.I am not skirmish about many things,but it will take 1 hour and when the woman showed me the catheter my eyes must have popped out of my head. I was thinking of something like the piping that we use of O2,no ways. I will give it to you in ft and ins.Its about a foot long and it can be between 1/4ins to 1/2 ins in dia,If you saw it laying on the floor,you would think it was a electrical or plumbing pipe . To spend 1 to 2 weeks in hospital,it cant be a small operation. I remember when I was in hospital xmas 2009 for copd, the first time ever(you remember).when they were not sure the O2 would be delivered before I got home.I said Ho,thats ok I can go tomorrow.My doctor said no ways the longer you say here the more chance you my get something else.There were about 30 of us in that ward and it was really old. Susanny, "It will take diligence to take care of each day." Yes sue I understand what you mean,but if I can have a better quality of life,I am prepared to do that,but I dont think I am prepaid to do that if knowing that sometime in the future after doing that,when they commercialize it and the NHS will not pay for it,or stop making it all together,and I am left with a hole in my chest.Will it get infected, will it close?. After all I am their Guinea pig. The Pneumostoma gets blocked (no air coming out) and in the 6 months could have to be reopened +- 3 times,2.5 months,and before they do it you have to provide your consent dose that mean you would have anesthetic every time When you have entered into the continued access phase of the study (this is your 6 month visit)ithe number of openings you may need is determined by you and your study doctor(so that seems to be on going. Plenty of questions to ask next Tuesday.
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Post by Blossom/Jackie W. on Jan 13, 2011 19:28:18 GMT -5
Zar.... just quickly read yous post..... and I SURE can appreciate what you're saying from a lot of aspects.....
If you don't mind; I'd like to think on it for a bit and I'm confident others would too!.... This is quite "different" for lack of a better word.....
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Post by zar on Jan 15, 2011 7:13:11 GMT -5
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Post by Deleted on Jan 25, 2011 15:15:33 GMT -5
I think you are displaying your normal sharpness Zar by forgoing the procedure AT THIS TIME.
At the present speed of scientific and technical change we can only imagine how crude and backward the procedure presented to you will seem to be in two years time .
While we need pioneers to help acheive progress it seems to me you are not desperate ..... yet.
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Post by zar on Jan 28, 2011 7:54:40 GMT -5
deetsk,
"At the present speed of scientific and technical change"
While I was there they were already talking about a "new pneumostoma" something similar to a scuba octopus valve and it states in the info sheets.
" You may fill that you would like to wait for information that it works first before taking part."
I have not given up yet but until then I am still a guinea pig there and they have more studies,so I don't think it will be long before my phone will starts to ring.
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