The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation) among subjects who failed to show improvement after initial treatment of the duodenal mucosa with RF vapor ablation.
The aims of the study are: 1. Evaluate the safety of the device and retreatment procedure based on the reported adverse events that occur. 2. Evaluate the effectiveness of the device and procedure by comparing change in HbA1c from baseline to 168 days post retreatment procedure. 3. Evaluate device tolerability based on pain scores reported by patients. The subject population for this study are adults (18-65 years of age) with type-2 diabetes mellitus who have received initial RF vapor ablation of the duodenal mucosa and had improvement in HbA1C of \<0.5% at their six month evaluation. Twelve subjects, previously enrolled in the STEAM T2DM Pilot study did not show adequate (\>0.5%) response to initial RF vapor ablation treatment of the duodenal mucosa. Minimum study duration per subject is 6 months. The study comprises of 5 phases: Screening, Pre-procedure tests, RF Vapor ablation procedure, Post vapor ablation follow up, identification and long term follow up of responders.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
RF Vapor ablation of the duodenum
Clinica Colonial
Santiago, Chile
Safety Endpoint
Number of subjects with reported device or procedure related SAEs or UADEs.
Time frame: 1 month
Efficacy Endpoint
Change in HbA1c from baseline to 168 days post retreatment procedure
Time frame: 168 days
Tolerability Endpoint
Descriptive statistics on Visual Analogue Scale(VAS) pain scores Descriptive statistics on Visual Analogue Scale(VAS) pain scores Descriptive statistics on Visual Analogue Scale (VAS) pain scores
Time frame: 14 days
Change in HbA1c at 84 days post retreatment procedure
Change in HbA1c at 84 days post retreatment procedure
Time frame: 84 days
Change in HbA1c over time
Change in HbA1c by visit over time
Time frame: 168 days
Change in FPG from baseline
Change in Fasting Plasma Glucose from baseline to 84 and 168 days post retreatment procedure
Time frame: 168 days
Change in FPG over time
Change in FPG change by visit over time (168 days post retreatment procedure)
Time frame: 168 days
Proportion of ablation-treated subjects with an improvement in HbA1c from baseline
Proportion of ablation-treated subjects with an HbA1c improvement from baseline at 168 days.
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Time frame: 168 days
Change in HOMA-IR
Changes in HOMA-IR by visit over time (168 days post procedure).
Time frame: 168 days
Change in UACR
Change in UACR from baseline to 168 days post retreatment procedure
Time frame: 168 days
Change in ALT
Change in ALT from baseline to 168 days post retreatment procedure.
Time frame: 168 days
Change in AST
Change in AST from baseline to 168 days post retreatment procedure.
Time frame: 168 days