Aqua Medical, Inc.

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 purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin.

The purpose of this clinical study is to test the hypothesis that RF vapor ablation of the duodenal mucosa will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation).
The main aims of the study are :
1. Evaluate the safety of the device and 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 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. Study participation is 6 months for each patient.
The study is comprised of 5 phases: Screening, Run-in, RF Vapor ablation procedure, and Post-vapor ablation follow-up (up to 168 days), Identification and long term follow up of responders