Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-02-01
2023-04-01
Brief Summary
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Detailed Description
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This clinical study will be conducted in accordance with this CIP. All parties involved in the conduct of the clinical study will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Treatment with Microbind® Affinity Blood Filter
Extracorporal therapy
Extracorporal therapy
Control
Antibiotics
No interventions assigned to this group
Interventions
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Extracorporal therapy
Extracorporal therapy
Eligibility Criteria
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Inclusion Criteria
2. Be ≥ 18 years old and ≤ 90 years old
3. Existing hemodialysis access
Exclusion Criteria
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
4. Have Child-Pugh Class C cirrhosis
5. Have platelet count \<30.000/uL
6. Contraindications for heparin sodium for injection
7. Subjects demonstrating any contraindication for this treatment as described in the IFU
8. Patients without existing hemodialysis access
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
ExThera Medical Europe BV
INDUSTRY
Responsible Party
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Principal Investigators
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Bartosz Tyczynski, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Essen
Locations
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University Hospital Essen
Essen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Bartosz Tyczynski, Dr.
Role: primary
Kristina Boss, Dr.
Role: backup
Other Identifiers
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CP026
Identifier Type: -
Identifier Source: org_study_id