Context: SatiSphere is a new endoscopically implantable device designed to delay transit time
of nutrients through the duodenum. It consists of a 1 mm nitinol wire with pigtail
ends and several mesh spheres mounted along its course, released in the duodenum and
gastric antrum to conform to the duodenal C loop configuration and thereby self-anchor.
Objective: To test safety, efficacy, and effect on body weight in a 2:1 randomized study, as
well as incretin secretion in a subgroup.
Methods and Results: Of 31 included cases (11 men, mean age 42.9 years, mean BMI 41.3 kg/m2), 21 patients treated with endoscopic SatiSphere insertion with scheduled device
removal after 3 months were compared with 10 controls. In 10 of 21 patients, device
migration occurred, in two cases necessitating emergency surgery, which led to termination
of the trial. Weight loss after 3 months was 6.7 kg, 4.6 kg, and 2.2 kg in the groups
completing therapy, all treatment cases using intention to treat (ITT) analysis, and
controls. Excess weight loss was significantly increased by Satisphere insertion (18.4%,
12.2%, and 4.4% in completers, ITT analysis group and controls; p = 0.02 for completers
vs. controls). Measuring glucose, insulin and glucagon like peptide 1 (GLP-1) following
a mixed meal test with the device in place and after removal (n = 7), SatiSphere delayed
glucose absorption and insulin secretion and altered kinetics in GLP-1 levels.
Conclusions: SatiSphere was short-term effective in reducing body weight, which might be mediated
through alterations in incretine metabolism. However, frequent device migration necessitates
device modifications.
