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Thread: The E-Stand clinical trial is suppose to start today ...

  1. #11
    Quote Originally Posted by tomsonite View Post
    What I am saying is that you can't infer that researchers "don't care about making this therapy available as soon as possible" just because the completion date is far off. That's an incredibly unfair insinuation.

    It is not a new device or surgical procedure, per se - the device is currently FDA approved and regulated for neuropathic pain.

    They are investigating if they can use this device differently, for a different purpose than what it was originally approved for (enhancing movement after SCI), hence the need for more studies and clinical trials.

    I agree that many people with SCI could benefit from it now. That doesn't change our laws, though. This new way of using this device must go through all processes necessary to become FDA approved and regulated, and thus have any chance of being covered by medical insurance. The will of the researchers won't change that.
    I agree. I don't see the value in guesses when having something implanted if they don't have the exact electrode placements and frequency sequences worked out to make the surgery as valuable and successful as possible. Thailand installs and send people home with little more than that. It's totally worthless if it's not dialed in to do anything or over works the tissue and muscles causing damage.

  2. #12
    100 people over 6 years. The point stands, they are not in any hurry.

  3. #13
    Quote Originally Posted by GRAMMY View Post
    I agree. I don't see the value in guesses when having something implanted if they don't have the exact electrode placements and frequency sequences worked out to make the surgery as valuable and successful as possible. Thailand installs and send people home with little more than that. It's totally worthless if it's not dialed in to do anything or over works the tissue and muscles causing damage.
    Grammy, I would be very interested to know details about what has been done by whom and to whom in Thailand and what the outcomes -- positive and negative -- have been. What have you learned? Thanks!

  4. #14
    I'm not sure why it says they are not actively recruiting when I was there two weeks ago for my eval.

    Completion date if off but once correct parameters are found, it's just a matter of 30 min surgery to get the implant.

  5. #15
    I do know of someone traveling there to get one this month. As far as I know ASIA score and other eval was done to measure outcomes, combined with therapy after return.

  6. #16
    The clinical trial.gov site may not have been updated yet. The "E Stand" trial is currently and have been recruiting off their website. LINK

  7. #17
    Quote Originally Posted by niallel View Post
    100 people over 6 years. The point stands, they are not in any hurry.
    They shouldn't be in a hurry. This is a product that is literally implanted into an injured central nervous system. Rushing it to market without working out all the details needed to ensure that it is safe and effective for everyone could ruin the lives of hundreds of thousands of people with SCI.

  8. #18
    Quote Originally Posted by tomsonite View Post
    They shouldn't be in a hurry. This is a product that is literally implanted into an injured central nervous system. Rushing it to market without working out all the details needed to ensure that it is safe and effective for everyone could ruin the lives of hundreds of thousands of people with SCI.
    My point has ZERO to do with safety, it has to do with speed and so was the initial point from Silvio. Please stop making out that we don't care about safety.

    They are doing 20 people a year. If they did 100 people in a year they would still have the same amount of information and it would be done in 2 years.

  9. #19
    Quote Originally Posted by tomsonite View Post
    They shouldn't be in a hurry. This is a product that is literally implanted into an injured central nervous system. Rushing it to market without working out all the details needed to ensure that it is safe and effective for everyone could ruin the lives of hundreds of thousands of people with SCI.
    I would add that they cannot be in a hurry. I know several organizations have been fundraising and working on the costs of the trials for each patient. One org was able to raise enough to run 2 people through the initial trials and the efforts have grown along with lots of time and work going into writing up grants for the dollars. There was never a pile of money available to begin with to do replication studies on 100 people.

  10. #20
    Yes you're right, every detail should be worked out especially safety wise before bringing it to the market, even though it's already believed to be safe enough. But still, 6 years seems like a bit too long, it's not like they're starting from scratch on some novelty kind of device, it's more like refining a product that's been worked on for years now. If funding wasn't a problem, and if they'd really aim to make it available ASAP, I imagine that even the 100 patients trial would be finished a lot quicker. In my opinion for some researchers there's no need to push things faster, because at the end of the day it's just a job for them, which is possible well paid, and why rushing...
    And by the way, there are other similar studies going on right now that I trust them to be out a lot sooner.
    And also I think that a lot of patients would rather "take the risk" and try it out before it's completely tested, instead of waiting for years and years. Some, if given the opportunity would happily even pay their way into the trials, me included

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