A safety and feasibility study of the delivery of energy pulses within the intestine.

This is a prospective, single-arm, interventional study evaluating the safety of a new device designed for the delivery of a low energy pulse to part of the intestine from inside the body. The new device is a gastroscope designed for endoscopic procedures within the gastrointestinal (GI) tract. Structurally and functionally, it resembles conventional gastroscopes used for diagnostic and therapeutic interventions. The device will be inserted through the mouth and the physician will guide the catheter to the location in the duodenum where the treatment will be applied. Upon positioning, energy will be delivered through the study device to the target area specified by the physician. The energy pulse will come from a generator and be delivered by a tool from inside the body that is similar in size to other commonly used tools. The energy provided is a non-thermal that will be delivered through the study device within the duodenum. Up to 9 locations in the duodenum may be treated under the investigator's discretion at a specific dosage. The duration of energy delivery is approximately 1 minute at each site. The procedure will last approximately 30 minutes. The treatment will be provided during the study procedure. There will be no additional treatments administered using the study device after the study procedure is completed. The study procedure will be performed by a highly trained gastroenterologist in an endoscopy suite. The gastroenterologist will be trained on the use of the device prior to the start of procedures. No study specific training is needed for any follow-up assessments. Adherence to the intervention will be assessed through follow-up visits performed by the study team as well as a review of medical records.