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Obesity / Intragastric Balloon · Observational Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational registry of the Orbera365 intragastric balloon, currently recruiting participants across EU centres. The study aims to monitor safety (serious adverse event rates) and treatment completion over 12 months in routine clinical practice, but no results have been posted in this registry record.
Observational. Obesity; age from 18 Years. Intervention: Intragastric Balloon. n = 200. 4 sites: Czechia, Spain, United Kingdom.
This is a prospective observational registry of the Orbera365 intragastric balloon, currently recruiting participants across EU centres. The study aims to monitor safety (serious adverse event rates) and treatment completion over 12 months in routine clinical practice, but no results have been posted in this registry record.
No results are posted in this registry record; efficacy and safety outcomes are not yet reported.
Once results are reported, this registry will provide real-world safety and completion data for the Orbera365 device in EU clinical practice. Clinicians should await publication of outcomes before drawing conclusions about device performance.
This is a prospective observational registry of an already-marketed device with no posted results; it is designed to monitor safety and completion rates in routine practice but carries no efficacy data and is not yet reported.
As stated by the source record.
Quoted from the source exactly as published.
Once results are reported, this registry will provide real-world safety and completion data for the Orbera365 device in EU clinical practice. Clinicians should await publication of outcomes before drawing conclusions about device performance.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07062094). This is a study registration, not published results. Lead sponsor: Boston Scientific Corporation. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Obesity. Interventions: DEVICE: Intragastric Balloon. Primary outcome measures: Rate of Subjects with Serious Adverse Events , Up to 12 months; Rate of Treatment Completers , Up to 12 months. Brief summary: This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.