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EXtension of Tablo TrEatmeNt Duration Registry

Completed
Conditions
Acute Kidney Injury
End Stage Renal Disease (ESRD)
End Stage Renal Disease on Dialysis
Interventions
Device: Tablo Hemodialysis System
Registration Number
NCT04912050
Lead Sponsor
Outset Medical
Brief Summary

Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
Inclusion Criteria
  • Participant weighs ≥ 34kg.
  • Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy > 12 hours.
Exclusion Criteria
  • Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Tablo Hemodialysis SystemTablo Hemodialysis SystemHospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours on the Tablo Hemodialysis System
Primary Outcome Measures
NameTimeMethod
Treatment SuccessUp to 24 hours

Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%

Secondary Outcome Measures
NameTimeMethod
Tablo Cartridge Lifeup to 24 hours

Measure the average number of cartridge changes required to complete a Tablo XT Treatment

Trial Locations

Locations (1)

St. Mark's Hospital

🇺🇸

Salt Lake City, Utah, United States

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