*3.1.6.2 Efficacy and safety profile*

Ten patients with a mean BMI of 41 kg/m<sup>2</sup> underwent the procedure in the first human pilot study [35, 36]. In this pilot, laparoscopy assistance was used to ensure adequate magnet coupling and verify limb lengths. The anastomosis was formed in approximately 1 week, and magnets were expelled without pain or obstruction. All anastomoses were patent at 2- and 6-month follow-up endoscopy. After 6 months, subject demonstrated a TBWL of 10.6%. After 1 year, EWL was 40.2%, and all anastomosis remained patent. No SAE occurred and reported nausea and diarrhea were self-limiting [37]. More investigations and applications of this promising procedure are underway [38].

#### **3.2 Gastric occupying devices**

## *3.2.1 Transpyloric shuttle*

The TransPyloric Shuttle (TPS) (BAROnova Goleta, CA, USA) is a gastric occupying device that is designed to delay gastric emptying and induce early and prolonged satiety [20]. The device consists of a spherical silicone orb that tapers into a tail tethered to a smaller cylindrical orb. After the device is delivered into the stomach through an overtube using a transluminal endoscopic procedure, the TPS moves freely in the stomach without the attachment to the tissue. Due to the physiological peristalsis, the small cylindrical orb will be pulled through the pylorus and reside in the duodenum. Because the base of the greater orb is compliant, it will self-position across the pylorus creating an intermittent seal intended to delay gastric emptying. Device removal is performed endoscopically, in which standard endoscopic graspers are used to unlock and retrieve the locking mechanism. Once unlocked, a standard endoscopic polypectomy snare can be used to retrieve the device.

**45**

*Endoluminal Techniques to Treat Obesity DOI: http://dx.doi.org/10.5772/intechopen.82733*

To date, only one feasibility study has investigated the safety and efficacy of

to TPS placement with treatment periods of either 3 or 6 months. Patients lost an average of 25.1 ± 14.0% of EWL in the 3-month group and those who had the device for 6 months lost an average of 41 ± 21.1%. Early device removal occurred in two patients because of acute onset of epigastric pain after 10.5 weeks and 5.5 months, respectively. After device removal, the complaints resolved immediately. No SAE were reported, and TPS insertion and removal procedures went without any problems. Gastric ulcer, localized in the antrum, occurred in 10 patients and was resolved by medication. The majority of adverse events reported were periprocedural and mild or moderate. However, the incidence of gastric ulcers prompted changes in the design of the TPS, with the new prototype now being studied in a

multicenter randomized sham-controlled trial in the United States [40].

The Full Sense Bariatric Device (BKFW LLC, Grand rapids, MI, USA) is another gastric occupying device that comprises an esophageal stent connected to a gastric disk. It is hypothesized that it aids weight loss by placing direct and continuous pressure on the distal esophagus and cardia portion of the stomach, thereby inducing satiety. The pressure should provide continuous gastric nerve stimulation and hormonal feedback mechanisms that signals a feeling of fullness to the brain, even

In unpublished data with three human subjects, the device reportedly showed a 28% EWL after 46 days. During a 6-month trial in an unknown number of subjects, the device demonstrated a median EWL of 80%. However, no peer-reviewed data

As early as 1980, the vagal system gained attention as a possible target in obesity treatment. Patients with peptic ulcer disease temporarily lost weight after truncal vagotomy [41, 42]. Only 10–20% of the vagal nerve fibers are composed of efferent fibers that control stomach activity, whereas the remaining 80–90% consist of afferent fibers that send signals regulating satiety and satiation [43]. With this in mind, application of electrical current to the stomach vagus nerve alters gastric myoelectrical activity. While the exact mechanism of action remains to be elucidated, bariatric pacing poses a new frontier in the treatment of severe obesity.

Vagal blocking therapy (VBloc therapy) has been suggested as a new approach to tackle morbid obesity. Instead of performing a permanent truncal vagotomy, it blocks the vagal nerves in an intermittent manner using electrical pulses generated

by the Maestro Rechargeable System (Enteromedics, St Paul, MN).

are currently available to determine its safety and efficacy [20].

**4. Bariatric pacing and gastric electrical stimulation**

were randomized

the TPS [39]. Around 20 patients with a mean BMI of 36 kg/m<sup>2</sup>

*3.2.1.1 Efficacy and safety profile*

*3.2.2 Full sense bariatric device*

when there is no food present.

*3.2.2.1 Efficacy and safety profile*

**4.1 Bariatric pacing**

*4.1.1 Maestro rechargeable system*
