EXtension of Tablo TrEatmeNt Duration Registry | NCT04912050

Studies
EXtension of Tablo TrEatmeNt Duration Registry

NCT04912050

Sponsor

Outset Medical

Status

Completed

Last Update Posted

Aug 12, 2022Actual

Enrollment

33Actual

Phase

Not provided

Conditions

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

Interventions

Tablo Hemodialysis System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2021Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

May 26, 2021

First Submission Date that Met QC Criteria

May 28, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2022

Last Update Posted Date

Aug 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tablo Hemodialysis System	Device	Renal Replacement Therapy between 12< to ≤ 24 hours.	Tablo Hemodialysis System

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Mark's Hospital		Salt Lake City	Utah	84124	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Only aggregated participant data is planned to be shared at this time.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 3, 2023
Reset	Dec 8, 2023
Release	May 29, 2026
Reset	Jun 24, 2026

Submission Tracking

Estimated Results First Submitted Date

Mar 3, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 3, 2023			Dec 8, 2023
May 29, 2026

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided