Considerations for clinical trial design with obesity-related devices

Abstract Diet and exercise as a first line therapy do not appear to adequately address the epidemic of obesity seen worldwide. In the US there have only been two devices legally marketed in the last 10 years intended to treat obesity, with many more under clinical investigation. New drugs have recently been approved and, although they appear to provide some benefit, the use of these is associated with many side-effects and with an uncertain sustained weight loss. Using the benefit–risk paradigm as a basis for future study design, this editorial discusses the significant issues associated with the clinical trials intended to provide data to support the safety and effectiveness of new devices for obesity. Some of these issues include the choice of the appropriate study end-points, duration of the study, the need for sham comparators, and patient preference. Ideas are then proposed for future studies to aid in getting new devices to market.