Actively Recruiting
Evaluation of the Safety and Performance of the Neocement® Inject P
Led by Bioceramed · Updated on 2026-02-04
80
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
B
Bioceramed
Lead Sponsor
L
Local Health Unit Barcelos/Esposende, Public Health Unit
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.
CONDITIONS
Official Title
Evaluation of the Safety and Performance of the Neocement® Inject P
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females (age > 18 years old);
- Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® Inject P;
- Patients who are able to sign an informed consent form (for data collection)
- Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;
- Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;
You will not qualify if you...
- Patients who are unable to understand consent and the objectives of the study;
- Signs of local or systemic acute/ active or chronic infections;
- Metabolic affections;
- Severe degenerative diseases, conditions in which general bone grafting is not advisable;
- Implementation sites that allow product migration;
- Conditions which require structural support in the skeletal system;
- Conditions where the implantation site is unstable and not rigidly fixated;
- Sensibility to the implantable materials;
- Known hypersensitivity to the implant material.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Unidade Local de Saúde Esposende/Barcelos
Barcelos, Portugal
Actively Recruiting
Research Team
A
Alexandre Barros
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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