Trials / Recruiting
RecruitingNCT05788432
Sequent Extended Study
Sequent Please Neo Extended Post-Market Clinical Follow-up Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,028 (estimated)
- Sponsor
- Fundación EPIC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sequent Please Neo | Patients in whom treatment with (Sequent Please Neo) has been attempted |
Timeline
- Start date
- 2023-03-28
- Primary completion
- 2026-06-01
- Completion
- 2026-07-01
- First posted
- 2023-03-28
- Last updated
- 2026-02-03
Locations
26 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05788432. Inclusion in this directory is not an endorsement.