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NCT04912050 Clinical Trial

EXtension of Tablo TrEatmeNt Duration Registry

Acute Kidney Injury Clinical Trial

— XTEND  

Official title:
EXtension of Tablo TrEatmeNt Duration Registry (XTEND)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04912050
Other study ID # 2020-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date May 31, 2022

Study information
Verified date August 2022
Source Outset Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Tablo Hemodialysis System
Renal Replacement Therapy between 12< to = 24 hours.

Locations
Country Name City State
United States St. Mark's Hospital Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Outset Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment Success Percentage of treatments achieving prescribed dialysis treatment time = 10% Up to 24 hours
Secondary Tablo Cartridge Life Measure the average number of cartridge changes required to complete a Tablo XT Treatment up to 24 hours
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