*3.1.3.2 Efficacy and safety profile*

Current literature on the efficacy and safety of this device consists of two-open label prospective single-arm trials and two randomized controlled trials [26–29]. In a multicenter randomized controlled trial in the United States, 221 patients received the POSE procedure combined with low-intensity lifestyle interventions for a period of 12 months [29]. They achieved a TBWL of 4.95 ± 7.04%, in comparison to 1.38 ± 5.58% in the control group, consisting of 111 patients who received lowintensity lifestyle intervention alone. Reported SAE were 4.7% (1.9% vomiting, 1.6% nausea, and 0.4% pain), which often occurred within the first week post-procedure and required extended hospital stay. In addition, 0.4% extra gastric bleeding and 0.4% liver abscess occurred which required, respectively, open surgery and percutaneous drainage [29, 30]. In another multicenter randomized controlled trial, POSE-treated subjects showed 30% TBWL after 12 months compared to 5.9% in the control group [28]. Furthermore, the POSE procedure has demonstrated to result in a significant improvement in satiation [31]. In conclusion, the POSE procedure is a promising option for the bariatric patient, but still requires further development.

#### *3.1.4 Endomina system*

The Endomina system (EndoTool SA [SST], Gosselies, Belgium) reduces gastric volume by creating an endoscopic gastroplasty alongside the greater curvature of the stomach [32].

#### *3.1.4.1 Technique*

By using an over-the-scope triangulation platform attached to an endoscope, anterior-to-posterior greater curvature plications are applied. While introducing a 5F needle preloaded with suture into the flexible arm of the platform, the stomach wall is mobilized and pulled back with a forceps. Under visual control, the needle pierces the stomach wall at the designated site, and a first tag, attached to the suture and a pre-tied knot, is released. The needle is retracted, the first plicature is released, and a second plicature can be made with the same action.

#### *3.1.4.2 Efficacy and safety profile*

A single-center, phase 1, prospective cohort study was initiated in May 2015, which demonstrated 11% TWBL after 6 months. No major adverse event was observed in the 10 patients who underwent the procedure [32]. In a multicenter prospective trial with 1-year follow-up, EWL and TBWL at 1 year were 29%

**43**

of 40.2 kg/m<sup>2</sup>

*3.1.5.1 Technique*

*locations in the stomach (from [34], with permission).*

**Figure 5.**

*3.1.5.2 Efficacy and safety profile*

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

with diet to diet alone is currently underway.

*3.1.5 Articular circular stapling device (ACE)*

(SD 28) and 7.4% (SD 7), respectively, for the whole cohort (45 patients). At

follow-up gastroscopy, 88% of sutures were still in place (30 patients). No SAE were observed [33]. A randomized controlled trial comparing the Endomina combined

The articular circular stapling device (**Figure 5**) (BaroSense, Redwood City, CA; Boston Scientific Corp., Marlbourough, MA) is an investigational device which applies full-thickness transmural plications of the stomach wall aided by vacuum and stapling.

With an outer diameter of 16 mm, the device has a built-in channel for a 5-mm endoscope. The stapler head, located at the distal part of the device, is able to rotate 360° and orientate into complete flexion or retroflexion. When introduced into the stomach, it is able to create a vacuum inside its silicone cover, to capture the desired amount of stomach tissue. After ensuring an adequate amount, the acquired piece of stomach tissue will be compressed by a 10-mm plastic ring with eight titanium staples, thereby creating a large, full-thickness transmural plication. After preloading the system with a new staple cartridge, creation of new plications can be continued in the same fashion. After a maximum of eight plications in the fundus together with an additional two in the antrum of the stomach, reduction of stomach volume alongside the greater curvature is completed. The two extra plications in the

*The ACE stapler: after the tissue is acquired by vacuum, plications are made with a circular staple ring in 10* 

This first reported human phase 1 study enrolled 17 patients with a median BMI

gastric pain (n = 7), sore throat (n = 4), diarrhea (n = 4), nausea (n = 3), and

who underwent the ACE procedure [34]. Adverse events involved

antrum of the stomach are believed to delay gastric emptying.

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

*Recent Advances in Laparoscopic Surgery*

*3.1.3.2 Efficacy and safety profile*

*3.1.4 Endomina system*

the stomach [32].

*3.1.4.1 Technique*

*3.1.4.2 Efficacy and safety profile*

In order to create full-thickness serosa-to-serosa plications, a special overtubestyle platform, the Transport Endoscopic Access Device (USGI medical) is used at the operative site [26]. It has four working channels through which an endoscope and three additional instruments can be introduced. The g-Prox EZ® Endoscopic Grasper, a flexible shaft with a gripper at the tip to mobilize and capture target tissue (**Figure 4A**); the g-Lix™ Tissue Grasper, a flexible probe which is designed to assist the g-Prox in capturing the desired tissue; and the g-Cath EZ™ Suture Anchor Delivery Catheter which is equipped with a needle at its distal tip, and facilitates the creating of plications by penetrating the mobilized tissue with a pair of pre-loaded suture anchors. This ensures anchoring of the fold until there is serosal fusion.

Current literature on the efficacy and safety of this device consists of two-open label prospective single-arm trials and two randomized controlled trials [26–29]. In a multicenter randomized controlled trial in the United States, 221 patients received the POSE procedure combined with low-intensity lifestyle interventions for a period of 12 months [29]. They achieved a TBWL of 4.95 ± 7.04%, in comparison to 1.38 ± 5.58% in the control group, consisting of 111 patients who received lowintensity lifestyle intervention alone. Reported SAE were 4.7% (1.9% vomiting, 1.6% nausea, and 0.4% pain), which often occurred within the first week post-procedure and required extended hospital stay. In addition, 0.4% extra gastric bleeding and 0.4% liver abscess occurred which required, respectively, open surgery and percutaneous drainage [29, 30]. In another multicenter randomized controlled trial, POSE-treated subjects showed 30% TBWL after 12 months compared to 5.9% in the control group [28]. Furthermore, the POSE procedure has demonstrated to result in a significant improvement in satiation [31]. In conclusion, the POSE procedure is a promising option for the bariatric patient, but still requires further development.

The Endomina system (EndoTool SA [SST], Gosselies, Belgium) reduces gastric volume by creating an endoscopic gastroplasty alongside the greater curvature of

By using an over-the-scope triangulation platform attached to an endoscope, anterior-to-posterior greater curvature plications are applied. While introducing a 5F needle preloaded with suture into the flexible arm of the platform, the stomach wall is mobilized and pulled back with a forceps. Under visual control, the needle pierces the stomach wall at the designated site, and a first tag, attached to the suture and a pre-tied knot, is released. The needle is retracted, the first plicature is

A single-center, phase 1, prospective cohort study was initiated in May 2015, which demonstrated 11% TWBL after 6 months. No major adverse event was observed in the 10 patients who underwent the procedure [32]. In a multicenter prospective trial with 1-year follow-up, EWL and TBWL at 1 year were 29%

released, and a second plicature can be made with the same action.

*3.1.3.1 Technique*

**42**

(SD 28) and 7.4% (SD 7), respectively, for the whole cohort (45 patients). At follow-up gastroscopy, 88% of sutures were still in place (30 patients). No SAE were observed [33]. A randomized controlled trial comparing the Endomina combined with diet to diet alone is currently underway.
