EXtension of Tablo TrEatmeNt Duration Registry (XTEND)

EXtension of Tablo TrEatmeNt Duration Registry (XTEND)

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; End Stage Renal Disease (ESRD); End Stage Renal Disease on Dialysis
• Intervention / Treatment: Device: Tablo Hemodialysis System

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • St. Mark's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tablo Hemodialysis System; Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours on the Tablo Hemodialysis System	Device: Tablo Hemodialysis System; Renal Replacement Therapy between 12< to ≤ 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Success	Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tablo Cartridge Life	Measure the average number of cartridge changes required to complete a Tablo XT Treatment	up to 24 hours

Collaborators and Investigators

• Sponsor: Outset Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Hemodialysis; AKI; Tablo; ESKD; Outset Medical
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Acute Kidney Injury
• Other Study ID Numbers: 2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregated participant data is planned to be shared at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No