Obesity Clinical Trial
Official title:
A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents
an alternative to the use of gastric bypass operative techniques as a means of re-routing
food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage
of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part
the bypass of bariatric surgery.
This study will be conducted at a single clinical site in Malaysia. Approximately 16
subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted
one week apart with the implantation of the second cohort triggered by the absence of major
technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the
first seven days.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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