EXtension of Tablo TrEatmeNt Duration Registry

NCT ID: NCT04912050

Last Updated: 2022-08-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-25

Study Completion Date

2022-05-31

Brief Summary

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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

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Conditions

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End Stage Renal Disease (ESRD) End Stage Renal Disease on Dialysis Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Tablo Hemodialysis System

Intervention Type DEVICE

Renal Replacement Therapy between 12\< to ≤ 24 hours.

Interventions

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Tablo Hemodialysis System

Renal Replacement Therapy between 12\< to ≤ 24 hours.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Outset Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Mark's Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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2020-03

Identifier Type: -

Identifier Source: org_study_id

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