EXtension of Tablo TrEatmeNt Duration Registry

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.

Completed

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Key information

Conditions

End Stage Renal Disease (ESRD) Acute Kidney Injury Chronic Disease Disease Attributes End Stage Renal Disease on Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tablo Hemodialysis System

Device

Renal Replacement Therapy between 12< to ≤ 24 hours.

Primary outcomes

Treatment Success

Time frame: Up to 24 hours

Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%

Secondary outcomes

Tablo Cartridge Life

Time frame: up to 24 hours

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

Sponsors and collaborators

Lead sponsor

Outset Medical

Industry

Registry information

Official study title

EXtension of Tablo TrEatmeNt Duration Registry (XTEND)

Acronym: XTEND

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 3, 2021
Registry last updated: Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed