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/m2) 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.)SCOPUS: ar.jinfo:eu-repo/semantics/publishe

DEVICE FOR SHEARING TISSUE

info:eu-repo/semantics/publishe

Magnets and a self-retractable wire for endoscopic septotomies: from concept to first-in-human use.

peer reviewedBACKGROUND: A medical device that allows simple and safe performance of an endoscopic septotomy could have several applications in the gastrointestinal (GI) tract. We have developed such a device by combining two magnets and a self-retractable wire to perform a progressive septotomy by compression of the tissues. We describe here the concept, preclinical studies, and first clinical use of the device for the treatment of symptomatic epiphrenic esophageal diverticulum (EED). METHODS: The MAGUS (MAgnetic Gastrointestinal Universal Septotome) device was designed based on previous knowledge of compression anastomosis and currently unmet needs. After initial design, the feasibility of the technique was tested on artificial septa in pigs. A clinical trial was then initiated to assess the feasibility and safety of the technique. RESULTS: Animal studies showed that the MAGUS can perform a complete septotomy at various levels of the GI tract. In two patients with a symptomatic EED, uneventful complete septotomy was observed within 28 and 39 days after the endoscopic procedure. CONCLUSIONS: This new system provides a way of performing endoluminal septotomy in a single procedure. It appears to be effective and safe for managing symptomatic EED. Further clinical applications where this type of remodeling of the GI tract could be beneficial are under investigation

Evolution of the feeding morphology in pacus and piranhas (Teleostei: Serrasalmidae)

SCOPUS: er.jinfo:eu-repo/semantics/publishe

Swallowable obalon® gastric balloons as an aid for weight loss: A pilot feasibility study

The goal of this study was to evaluate the safety and the impact on weight loss of a new swallowable gastric balloon. In this prospective pilot study, 17 overweight or obese patients were included. Up to three balloons were ingested under fluoroscopic control. All balloons were removed by upper GI endoscopy, 12 weeks after the ingestion of the first balloon. 43 out of 44 attempts (98 %) to swallow a balloon were successful. Nausea and stomach pain were the most frequent side effects. Endoscopic procedures for balloon removal were uneventful. Weight loss was significant at weeks 4, 8, and 12. This pilot study showed no significant side effects induced by up to three balloons, and a significant weight loss. © 2013 Springer Science+Business Media New York.SCOPUS: ar.jinfo:eu-repo/semantics/publishe