http://diabetes.org/diabetesnewsarti...ntalusEDIT.xml
or
http://tinyurl.com/yp38wg
(excerpt)
ADA Comments:
ORANGEBURG, N.Y., Nov 28, 2007 /PRNewswire via COMTEX/ -- MetaCure
Limited, today announced that it began patient enrollment in a
national diabetes clinical trial of its TANTALUS(R) System, an
investigational device being tested in patients with type 2 diabetes
who are overweight. The study is being conducted in up to 30 sites in
the United States. The 300-patient trial will evaluate the TANTALUS,
an implantable device that delivers electrical pulses to the stomach
when a person eats. The primary objective of the randomized, double-
blind controlled study is to evaluate the TANTALUS System in treating
patients who have type 2 diabetes
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28-NOV-2007
MetaCure(TM) Launches Investigational Study of Gastric Stimulator for
Patients With Type 2 Diabetes Who are Overweight-- First Patient
Implanted in San Antonio, TX -
ORANGEBURG, N.Y., Nov 28, 2007 /PRNewswire via COMTEX/ -- MetaCure
Limited, today announced that it began patient enrollment in a
national diabetes clinical trial of its TANTALUS(R) System, an
investigational device being tested in patients with type 2 diabetes
who are overweight. The study is being conducted in up to 30 sites in
the United States.
The 300-patient trial will evaluate the TANTALUS, an implantable
device that delivers electrical pulses to the stomach when a person
eats. The primary objective of the randomized, double-blind controlled
study is to evaluate the TANTALUS System in treating patients who have
type 2 diabetes and are overweight. Impact on blood glucose levels,
weight loss, blood pressure and other clinical and metabolic
parameters will be studied. To be considered for the trial, patients
must meet certain inclusion criteria, including a diagnosis of type 2
diabetes with a body mass index (BMI) between 28 and 45 kg/m2 and ages
18 to 70.