Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers

NCT05713188 | Completed Phase 1 DMC

• 1 other identifier: MediSieve FMS study
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers

Conditions

Haemofiltration

Outcome Measures

Primary Outcomes (1)

• Safety (Adverse events)

  Incidence of (serious) adverse events and device deficiencies during haemofiltration until 7 days post-filtration

  Continuously starting from 2 hours prior of the start of haemofiltration until 7 days post-filtration

Secondary Outcomes (16)

• Safety (Blood pressure)

  From 2 hours prior until 7 hours after start of haemofiltration.

• Safety (Heart rate)

  Continuously from 2 hours prior until 7 hours after start of haemofiltration.

• Safety (Temperature)

  Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.

• Safety (Symptoms)

  Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.

• Safety (Immunology)

  Samples will be obtained from 1 hour prior until 7 days after start of haemofiltration.

Study Arms (1)

Treatment

EXPERIMENTAL

All volunteers will receive the same treatment

Device: MediSieve Magnetic Haemofiltration System

Interventions

MediSieve Magnetic Haemofiltration System DEVICE

The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours.

Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, ≥18 and ≤50 years of age
• Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.

You may not qualify if:

• BMI \<18.5 or \>30 kg/m2
• Chronic medication use (except contraception)
• Pregnant or lactating females
• Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
• History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)
• History or signs of haematological disease
• History or signs of thromboembolic disorders
• History of (intracranial) aneurysmal or haemorrhagic diseases
• History of any disease associated with immune deficiency
• History of cancer in the last 5 years (excluding localised skin cancer or CIS)
• History of heparin-induced thrombocytopenia (HIT)
• History of peptic / gastric ulcer disease
• Family history of haemorrhagic or thromboembolic disorders (\<50 years of age)
• Thrombocytopenia (\<150\*109/ml) or anaemia (males: haemoglobin \< 8.0 mmol/L, females: haemoglobin \< 7.4 mmol/L)
• History, signs or symptoms of cardiovascular disease, in particular:

Sponsors & Collaborators

• MediSieve Limited: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Study Officials

• Matthijs Kox, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 6, 2023
• Study Start: June 13, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 30, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

NL (1)