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FDA Clinical Trial, Orbasone ESWT in NYC

Posted by John M on 9/25/02 at 09:45 (096181)

Orbasone, the manufacturers of a new ESWT Pain Relief System, is conducting an FDA approved clinical study for the treatment of proximal plantar fasciitis. New York location is at the Clinic of Manhattan Podiatry Associates, under the direction of Dr. John E. Mancuso, DPM. This is a Double-Blinded Placebo study with an end point at 12 weeks. The FDA has set up certain inclusion and exclusion criteria for participation. Basically, the patient must have had symptomatic proximal fasciitis and failed conservative care for at least six months. The pain must be unilateral , no previous heel surgery and non-diabetic. Office location is: 133 East 54 Street, NY,NY 10022. Tele. #(212) 759-9090,
E-Mail:(email removed). Inquiries welcome.

Re: Why bother??

BrianG on 9/25/02 at 17:59 (096217)

I have one question. Why would anyone want to go through all the FDA trials for a machine that is outdated? According to Dr. Z, they are LOUD, and require a lot of maintenance to keep running. Not to mention the high cost of the spark plugs. Why bother?????

Regards
BrianG

Re: Dr. Mancuso, are you still reading ??

BrianG on 9/29/02 at 21:36 (096490)

Hi Dr. Mancuso,

I want to let you know that when I wrote my post, I did not put two and two together, realizing that the poster was the Pod running the trials. If I had, I'm sure I wouldn't have been so curt, sorry about that.

I am wondering how you are doing at lining up people for your trials? I do know that Dornier filled their open slots in record time, when they did their trials. I had heard that someone was going to pacify the FDA with the Orbie trials, but I wasn't sure if it was just a rumour. I know that the unit can be used as both a high, and low ESWT machine, I just wonder about it's future, since it had such a murkey start. Would you care to give us an update?

Regards
BrianG

Re: FDA Clinical Trial, Orbasone ESWT in NYC

Rich on 10/29/02 at 12:57 (098563)

Thanks for the information. I have been suffering with PF for 4 yrs and after reading your message scheduled a appointment to see Dr Mancuso. I decided to go forward and had the procedure which was done on Oct. 25. Since it was a double blind study, I am not sure I received the ESWT. The procedure took about 45 minutes and my foot was slightly bruised afterwards. It is still hurting as I write this 4 days later. I will go back to Dr. Mancuso in 30, 60 & 90 days to evaluate the progress.....hopefully it improves.

Re: Why bother??

BrianG on 9/25/02 at 17:59 (096217)

I have one question. Why would anyone want to go through all the FDA trials for a machine that is outdated? According to Dr. Z, they are LOUD, and require a lot of maintenance to keep running. Not to mention the high cost of the spark plugs. Why bother?????

Regards
BrianG

Re: Dr. Mancuso, are you still reading ??

BrianG on 9/29/02 at 21:36 (096490)

Hi Dr. Mancuso,

I want to let you know that when I wrote my post, I did not put two and two together, realizing that the poster was the Pod running the trials. If I had, I'm sure I wouldn't have been so curt, sorry about that.

I am wondering how you are doing at lining up people for your trials? I do know that Dornier filled their open slots in record time, when they did their trials. I had heard that someone was going to pacify the FDA with the Orbie trials, but I wasn't sure if it was just a rumour. I know that the unit can be used as both a high, and low ESWT machine, I just wonder about it's future, since it had such a murkey start. Would you care to give us an update?

Regards
BrianG

Re: FDA Clinical Trial, Orbasone ESWT in NYC

Rich on 10/29/02 at 12:57 (098563)

Thanks for the information. I have been suffering with PF for 4 yrs and after reading your message scheduled a appointment to see Dr Mancuso. I decided to go forward and had the procedure which was done on Oct. 25. Since it was a double blind study, I am not sure I received the ESWT. The procedure took about 45 minutes and my foot was slightly bruised afterwards. It is still hurting as I write this 4 days later. I will go back to Dr. Mancuso in 30, 60 & 90 days to evaluate the progress.....hopefully it improves.