Boston Scientific ((BSX)) announced an update on their ongoing clinical study.
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Boston Scientific is conducting a study titled ‘Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry.’ The study aims to evaluate the safety and effectiveness of the Orbera365™ Intragastric Balloon (IGB) System for weight loss in subjects within the EU. This registry is significant as it provides insights into the real-world application of the device in managing obesity.
The intervention being tested is the Orbera365™ Intragastric Balloon, a device designed to aid weight loss by occupying space in the stomach. It is used alongside a supervised diet and behavior modification program to enhance long-term weight loss maintenance.
The study is observational, following a case-only model with a prospective time perspective. Participants will be observed over a 13-month period, including the in-dwell period of the device and a follow-up visit 30 days post-removal.
The study is not yet recruiting, with a start date set for June 24, 2025. The primary completion and estimated completion dates are yet to be announced. The last update was submitted on September 26, 2025, indicating ongoing preparations for the study’s commencement.
This update could positively influence Boston Scientific’s stock performance by showcasing their commitment to innovative obesity treatments. Investors may view this as a strategic move to capture market share in the weight management industry, potentially affecting competitor dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.