Background: A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. Methods: Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. Results: In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P <.01). The second trial enrolled 27 patients (mean body mass index 39.3 ± .8 kg/m2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7% ± 3.1%, n = 24) compared with the initial study and first-generation device (14.2% ± 2.2%, n = 29, P = .03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P = .03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. Conclusion: This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.
Bibliographical noteFunding Information:
This clinical study was funded by EnteroMedics Inc.
Copyright 2009 Elsevier B.V., All rights reserved.
- Electrical vagal block
- Intermittent vagal block
- Laparoscopic surgery