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NotablePrimary completion pushed from Jun 1, 2026 to Dec 1, 2026Trial status changed: Recruiting → Active, Not Recruiting · Completion pushed from Jul 1, 2026 to Dec 1, 2026 · Enrollment target: estimated 2028 to confirmed 2040 · 1 morev24Show 4 more changesShow less
Trial status changed: Recruiting → Active, Not Recruiting
Completion pushed from Jul 1, 2026 to Dec 1, 2026
Enrollment target: estimated 2028 to confirmed 2040
Site details revised at 27 of 27 sites
MinorStudy sites: 26 to 27v23
NotableEnrollment target: 1000 to 2028v22
MinorStudy sites: 25 to 26v21
NotablePrimary completion date: Jun 1, 2025 to Jun 1, 2026Completion date: Jul 1, 2025 to Jul 1, 2026v20Show 1 more changeShow less
Completion date: Jul 1, 2025 to Jul 1, 2026
Show 18 earlier versionsHide 18 earlier versions
MinorStudy sites: 24 to 25v19
MinorStudy sites: 23 to 24v18
MinorStudy sites: 22 to 23v17
MinorStudy sites: 21 to 22v16
NotablePrimary completion date: Dec 1, 2024 to Jun 1, 2025v15
MinorPrimary completion date: Jul 1, 2024 to Dec 1, 2024v14
MinorStudy sites: 20 to 21v13
MinorStudy sites: 19 to 20v12
MinorStudy sites: 18 to 19v11
MinorStudy sites: 17 to 18v10
MinorStudy sites: 16 to 17v9
MinorStudy sites: 15 to 16v8
MinorStudy sites: 14 to 15v7
MinorStudy sites: 12 to 14v6
MinorStudy sites: 9 to 12v5
MinorStudy sites: 8 to 9v4
MinorStudy sites: 7 to 8v3
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 7 · Start date changed from estimate of Mar 30, 2023 to Mar 28, 2023v2Show 2 more changesShow less
Study sites: 0 to 7
Start date changed from estimate of Mar 30, 2023 to Mar 28, 2023
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.