NCT06736457 Study on Safety and Performance of AdvanCore Bone Void Filler
| NCT ID | NCT06736457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Artur Salgado SA |
| Condition | Bone Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2025-05-29 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
Eligibility Criteria
Inclusion Criteria: * Adult subjects ≥ 18 years old, male or female. * Subjects who are eligible for a bone grafting/bone void filler procedure. * Subjects with bone lesions beyond the limits of the bone's self-healing ability. * Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center. * Subjects with only one fracture susceptible to treatment with an AdvanCore implant. Exclusion Criteria: * Subjects with any AdvanCore contraindication for implantation or use. * Subjects with hypersensitivity to any of the AdvanCore components. * Subjects with infections or soft/granulation tissue in the area to place bone graft. * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. * Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06736457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06736457 currently recruiting?
Yes, NCT06736457 is actively recruiting participants. Contact the research team at f.costa@artursalgado.pt for enrollment information.
Where is the NCT06736457 trial being conducted?
This trial is being conducted at Guimarães, Portugal, Porto, Portugal, Tomar, Portugal, Lordelo, Portugal.
Who is sponsoring the NCT06736457 clinical trial?
NCT06736457 is sponsored by Artur Salgado SA. The trial plans to enroll 190 participants.