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.
• Age ≥ 22 and < 65 years, estimated life expectancy ≥ 2 years;
• BMI ≥ 30 and < 40 kg/m2;
• HbA1c ≥ 8.0 and ≤ 11%;
• Fasting Glucose (FG) ≥ 126 mg/dL;
• Under active medical care with ≥ 6-months treatment on ≥ 2 anti-diabetic medications;
• T2DM diagnosed ≤ 10 years prior to enrollment;
• Non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/l);
• Willing and able to provide informed consent, comply, and be geographically stable