The purpose of this study is to assess the safety, tolerability and effectiveness of RF vapor ablation of the proximal intestinal mucosa. This study will test the hypothesis that RF vapor ablation will result in improvement in glycemic parameters, without Serious Adverse Events (SAE) or Unanticipated Adverse Device Effects (UADE).
Men and non-pregnant women 22-65 years of age
Diagnosed with T2DM for at least 1 year and less than or equal to 15 years
HbA1C of 7.5 - 10% (58-86 mmol/mol)
BMI ≥ 24 and ≤ 40 kg/m2
Diagnosis of Type-1 Diabetes
History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
Probable insulin production failure, defined as serum C-peptide of 0.3-0.6 nmol/l.
Current or previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes) in the last 2 years.
Single group
RF Vapor Ablation
DeviceRF Vapor ablation of the proximal intestinal mucosa
Safety endpoint
Number of subjects with reported device or procedure related SAEs or UADEs.
Tolerability endpoint
Descriptive statistics on Visual Analogue Scale(VAS) pain scores (A Visual Analog Scale (VAS) pain score is a patient's self-reported measure of pain intensity, marked on a straight line scale from 0-10, with "no pain" at the zero-end and "worst imaginable pain" at 10.)
Efficacy endpoint
Change in HbA1c from baseline to 6 months post procedure
Change in HbA1c at 3 months post procedure
Change in HbA1c (from baseline) at 3 months post procedure will be analyzed
Change in FPG from baseline to 3 months and 6 months post procedure
Change in Fasting Plasma Glucose from baseline to 3 months and 6 months post procedure
Proportion of ablation-treated subjects with an HbA1c improvement > 0.5% from baseline at 6 months.
Proportion of ablation-treated subjects with an HbA1c improvement \> 0.5% from baseline at 6 months.
Change in HOMA-IR from baseline to 6 months post procedure.
Change in HOMA-IR from baseline to 6 months post procedure.
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