Do metals released from implanted medical devices reach the brain?

Do metals released from implanted medical devices reach the brain? - Brainmetals

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57587

Enrollment

Registered

2025-05-12

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

om dierproeven te vervangen met een 'organ-on-chip' platform not applicable

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients whose orthopedic surgery is planned and where it is decided to use spinal anesthesia will be informed by the attending orthopedist in Spaarne Gasthuis that they can participate in this study. They will be given the information letter. If they indicate an interest in participating in this study, their pre-surgery anesthesia consultation will be combined with a consultation with the ACTA researcher (at the Spaarne Gasthuis location). They will also be sent a bottle to take morning urine. The researcher will give a verbal explanation of the study, answer any questions and, if the patient wishes to participate, will also perform an oral examination. The follow-up, collection of CSF and blood will be performed during surgery.

Exclusion criteria

Exclusion criteria: Age under 18 or above 80 Legally incompetent adults

Design outcomes

Primary

Measure	Time frame
Blood and CSF handling and analysis (ACTA),(month 1-12): Blood (60) and CSF(41) samples will be analysed to determine the concentrations of the metals using ICP-MS, and compared with metals in dental and medical implants using ACTA*s micro-sampling techniques, EDAX and SEM. Correlation of clinical data with results obtained from the Body Barriers platform (ACTA),(month 12-48): Determination of whether metals observed in blood also pass the in vitro mucosa blood barrier into the microfluidics compartment of the TissUse bioreactor chip. Determination of whether metals observed in CSF are also detected passing the BBB of the Body Barriers platform thus coming into contact with brain organoids Deliverables/Milestones: Completed analysis of metals in dental medical devices and correlation to blood & CSF (month 12) Correlation of clinical data with Body Barriers (month 48)	—

Measure

Time frame

Blood and CSF handling and analysis (ACTA),(month 1-12): Blood (60) and CSF(41) samples will be analysed to determine the concentrations of the metals using ICP-MS, and compared with metals in dental and medical implants using ACTA*s micro-sampling techniques, EDAX and SEM. Correlation of clinical data with results obtained from the Body Barriers platform (ACTA),(month 12-48): Determination of whether metals observed in blood also pass the in vitro mucosa blood barrier into the microfluidics compartment of the TissUse bioreactor chip. Determination of whether metals observed in CSF are also detected passing the BBB of the Body Barriers platform thus coming into contact with brain organoids Deliverables/Milestones: Completed analysis of metals in dental medical devices and correlation to blood & CSF (month 12) Correlation of clinical data with Body Barriers (month 48)

—

Secondary

Measure	Time frame
As a by-product, information is obtained about which metals from dental and medical devices can be found in the peripheral blood and/or cerebrospinal fluid (CSF).	—

Countries

Netherlands

Outcome results