Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video).

BACKGROUND AND AIMS

Obesity is a major pandemic disease. Surgical therapy is highly effective, but its availability will likely be overwhelmed by the burden of the disease. Endoscopic technologies that could reproduce some of the clinical effects of surgery may become part of the treatment armamentarium. A simple transoral restrictive procedure could play a role in first-line surgical management.

METHODS

We evaluated the safety and feasibility of transmural suturing using a simple triangulation platform for gastric volume reduction through the creation of multiple double plicatures.

RESULTS

Between May and July 2015, 11 obese (body mass index 34.6 ± 2.1 kg/m) patients (mean age, 36 ± 10 years) underwent gastroplasty through transmural endoscopic sutures (performed using a triangulation platform and an endoscopic stitcher). The median duration of the procedure was 2.00 hours (range, 1.15-3.15 hours) and dramatically decreased after the first 5 cases. No severe adverse events were observed. Mean (standard deviation) weight loss and percentage of excess weight loss were 5.8 kg (2.7%) and 21% (9%) at 1 month (n = 11), 8.8 kg (4.9%) and 33% (22%) at 3 months (n = 10), and 10.9 kg (7.3%) and 41% (33%) at 6 months (n = 10).

CONCLUSIONS

Transoral endoscopic gastroplasty performed using a simple triangulation platform and a dedicated suturing device appears to be safe and effective at mid-term follow-up in creating gastric restriction and inducing weight loss in this first-in-humans experience. (Clinical trials registration number: NCT02534662.).