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Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')

StatusRecruiting
PhaseNot applicable
Started2026-06-03
View on ClinicalTrials.gov ↗

Amendment history

2026-08-26
minor
3 amendments v10-v12
3 re-verifications since 2026-06-28, no change to tracked fields
2026-06-10
notable
Study Status, Contacts/Locations v9
Recruitment opened
Start dateestimated 2026-06-30→confirmed 2026-06-03
2026-05-28
notable
Study Status v8
Primary completion pushed: 2028-04-30 → 2028-06-30
Completion pushed: 2028-10-31 → 2028-12-31
Start date2026-05-30→2026-06-30
2026-04-24
minor
5 amendments v3-v7
5 re-verifications since 2025-12-26, no change to tracked fields
2025-11-23
minor
Study Status v2
Start date2026-04-30→2026-05-30
2025-11-13
minor
Study Status v1
Re-verified, no change to tracked fields
2025-09-25
minor
Original filing
To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.
Trial Details
NCT Number NCT07195708
Lead Sponsor Boston Scientific Corporation
Conditions Weight Loss
Enrollment 144 participants
Start Date 2026-06-03
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-25