Obesity Clinical Trial
Official title:
Single Arm Study of Neurotronic Fully Endoscopic Jejunoileal Side-to-side Anastomosis for Treatment of Obesity and Type II Diabetes: The Neujia 1A Trial
This prospective, multicenter, open label, single arm study will enroll subjects presenting with obesity and inadequately controlled type II diabetes (T2DM). A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
For many obese diabetics, medical treatment and lifestyle modification fail to provide
acceptable glucose levels or durable weight loss. Bariatric surgical procedures have been
proven to provide better glycemic control and to improve life expectancy and quality of life.
But these are invasive procedures with significant complications, and notwithstanding the
strong clinical evidence and consensus guidance, less than 2% of patients who would benefit
from bariatric surgery choose to undergo the invasive procedures. There is therefore a
significant unmet clinical need for metabolic/bariatric therapies that result in durable
improvement in glycemic control, decreased anti-diabetic medication requirements, and weight
loss, with fewer and less severe complications than invasive bariatric surgery.
Human clinical data suggests that partial diversion through a side-to-side jejunoileal
anastomosis results in an absolute decrease in HbA1c of 1.9 to 3.6 percentage points and a
decrease in total weight of 9.6 to 14.6% at 12 months. Although these studies used other
methods, they provide good evidence that the anastomosis created by Neujia should be expected
to safely improve glycemic control.
A minimally invasive anastomosis device (Neujia) and endoscopic delivery system have been
developed to create a side-to-side jejunoileal anastomosis. One device is deployed in the
jejunum, approximately 30 to 100 cm distal to the ligament of Treitz, and the other in the
ileum, approximately 30 to 100 cm proximal to the ileocecal valve. The devices are mated
under endoscopic guidance with fluoroscopic visualization and create a compression
anastomosis. Neujia has the potential to provide a fully endoscopic, incisionless procedure
that achieves durable weight loss and glycemic control without the risks of bariatric
surgery. The proposed single arm study is designed to assess the feasibility and safety and
efficacy of the Neujia device when used to treat T2DM and obesity. Subjects are followed for
12 months and annually thereafter for up to 5 years to assess change in metabolic parameters,
medications, weight, and adverse events.
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