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Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI

NCT03795038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-28

No results posted yet for this study

Summary

The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.

Conditions

Interventions

DEVICE

Lipoprotein Apheresis MONET and DALI

Three apheresis treatments assigned to one type of apheresis system of MONETand DALI

DEVICE

Lipoprotein Apheresis DIAMED and DALI

Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI

Sponsors & Collaborators

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Heinrich Prophet, Dr. med. · Nephrocare Rostock GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-28
Primary Completion
2021-05-25
Completion
2021-05-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795038 on ClinicalTrials.gov