A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System
NCT ID: NCT04655989
Last Updated: 2021-10-06
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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COMPLETED
NA
31 participants
INTERVENTIONAL
2020-11-30
2021-05-01
Brief Summary
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Detailed Description
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The study population will include eligible adult patients diagnosed with chronic renal failure requiring routine dialysis treatments for a minimum of 90 days and with a minimum of 3 weekly sessions. Treatment duration will be at the discretion of the investigator. The duration of study participation for each subject is approximately eight (8) weeks; four (4) weeks of routine dialysis and four (4) weeks of treatment dialysis. The expected total study duration across all subjects (from recruitment to last subject visits) is approximately five (5) to six (6) months, dependent upon subject recruitment/enrollment and meeting 360 evaluable treatments. A minimum of 30 eligible subjects will be enrolled into the study ensuring a minimum of 360 evaluable treatments in the treatment arm.
The sub-study, VARRM, was conducted following the subject's completion of the primary eight (8) week clinical study. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Subjects that participated in the VARRM sub-study had their vascular recirculation rates collected during treatments. A minimum of 12 subjects were expected to participate in this sub-study, with a minimum of 21 and maximum of 36 dialysis accesses evaluated.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Group B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group).
After completion of the initial 8-week treatment period, subjects were eligible for the Vascular Access Recirculation Rate Measurement (VARRM) sub-study.
TREATMENT
NONE
Study Groups
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Routine first
Group A subjects will be assigned to 4 weeks of routine dialysis (control group) followed by 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group).
DBB-EXA ES Hemodialysis System
The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
Investigational first
Group B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group).
DBB-EXA ES Hemodialysis System
The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
VARRM sub-study
Following completion of the initial 8-week treatment, subject's were eligible to participate in the sub-study, VARRM. The total participation time for the VARRM sub-study was approximately 1.5 weeks.
DBB-EXA ES Hemodialysis System
The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
Interventions
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DBB-EXA ES Hemodialysis System
The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
Eligibility Criteria
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Inclusion Criteria
2. Chronic renal failure diagnosis
3. Minimum of 90 days of stable hemodialysis treatment with a minimum of 3 treatment sessions per week. The duration of each treatment session is in the discretion of the investigator.
4. Reliable vascular access
5. Hemodialysis treatment a minimum of three (3) sessions per week
6. Subject agrees not to eat or drink during treatments
7. Understand and sign the informed consent form
Exclusion Criteria
2. Hypercoagulation diagnosis
3. Hyperviscosity diagnosis
4. Most recent hemoglobin less than 9
5. Active bacterial infection
6. Women of childbearing potential, pregnant and/or lactating females verified by urine or serum pregnancy test
7. Life expectancy less than 6 months
8. Cognitive impairment, dementia, or other condition that limits the ability to provide informed consent and to comply with study procedures, or any other reason that the Investigator believes to contraindicate study participation.
9. Current or known future need for a central venous catheter (CVC)
10. Involved in another clinical research trial within the prior 30 days
11. Diagnosed with systemic consistent hypotension as defined by being systolic \<90 mm Hg or diastolic \<60 mm Hg
12. Immunocompromised patients (e.g. active malignancy, current chemotherapy treatment, transplant recipients, any patient on immunosuppressive medication, or patients with current autoimmune disease).
18 Years
ALL
No
Sponsors
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NAMSA
OTHER
Nikkiso America, Inc.
INDUSTRY
Responsible Party
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Robert Provenzano, MD
Consultant -Office of Chief Medical Officer
Locations
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Great Lakes Dialysis
Detroit, Michigan, United States
Great Lakes Dialysis - West
Southfield, Michigan, United States
Countries
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Other Identifiers
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DBB-EXA ES-001
Identifier Type: -
Identifier Source: org_study_id
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