*3.2.1.1 Efficacy and safety profile*

*Recent Advances in Laparoscopic Surgery*

*3.1.6 The incisionless magnetic anastomosis system*

assembling magnets.

*3.1.6.2 Efficacy and safety profile*

procedure are underway [38].

**3.2 Gastric occupying devices**

*3.2.1 Transpyloric shuttle*

Ten patients with a mean BMI of 41 kg/m<sup>2</sup>

*3.1.6.1 Technique*

constipation (n = 4), but resolved with conservative treatment within 15 days after surgery. No SAE occurred. Patients demonstrated a median % EWL of 34.9% (IQR 17.8–46.6) in the first year. This phase 1 study showed that the ACE stapler is safe and effective in humans. The study was funded by Barosense until sufficient funds could no longer been raised and further research was discontinued. However, randomized controlled trials and long-term follow up are needed to determine its place in the treatment of obesity. With acquisition by Boston Scientific Group, follow-up

research on the ACE procedure may be on the horizon in the near future.

The incisionless magnetic anastomosis system (IMA) manufactured by GI Windows (Boston, MA) is a compression anastomosis technology used to create a dual-path enteral bypass in the small bowel with the use of octagon shaped self-

Under fluoroscopic guidance, self-assembling magnets are delivered in the proximal jejunum and ileum by simultaneous upper and lower endoscopy. After deployment and coupling due to the magnetic field, the tissue in between will be pressed against each other causing necrosis. The necrotized tissue induces remodeling of the surrounding tissue, leading to the formation of a jejunal-ileal anastomosis. After the anastomosis has been established, the coupled magnets will be expelled by the feces.

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

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.

underwent the procedure in the first

**44**

To date, only one feasibility study has investigated the safety and efficacy of the TPS [39]. Around 20 patients with a mean BMI of 36 kg/m<sup>2</sup> were randomized 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].
