End Stage Renal Disease (ESRD)XTENDNCT04912050
EXtension of Tablo TrEatmeNt Duration Registry
An observational study of End Stage Renal Disease (ESRD) and End Stage Renal Disease on Dialysis, run by Outset Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease (ESRD), End Stage Renal Disease on Dialysis, Acute Kidney Injury
- What is being tested?
- Tablo Hemodialysis System
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 31 May 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours.
Who may be able to join
- 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.
Who cannot join
- Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Tablo Hemodialysis System
- Keywords
- Tablo, Outset Medical, Hemodialysis, AKI, ESKD
- Medical subject headings
- Kidney Failure, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablo Hemodialysis SystemDevice
Renal Replacement Therapy between 12< to ≤ 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Tablo Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%
Measured: Up to 24 hours
Secondary outcomes (1)
Tablo Cartridge Life
Measure the average number of cartridge changes required to complete a Tablo XT Treatment
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start25 May 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Outset Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912050
- Sponsor's protocol ID
- 2020-03
- Acronym
- XTEND
- Status last verified
- Aug 2022
- First submitted
- 26 May 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only aggregated participant data is planned to be shared at this time.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXtension of Tablo TrEatmeNt Duration Registry (XTEND)
- ClinicalTrials.gov ID
- NCT04912050
- Acronym / sponsor ID
- XTEND / 2020-03
- Keywords
- Tablo, Outset Medical, Hemodialysis, AKI, ESKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Outset MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tablo Hemodialysis System | – | Device: Tablo Hemodialysis SystemHospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours on the Tablo Hemodialysis System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy > 12 hours.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablo Hemodialysis SystemRenal Replacement Therapy between 12< to ≤ 24 hours. | Device | Tablo Hemodialysis System |
Primary outcome
Treatment Success
Time frame: Up to 24 hours
Percentage of treatments achieving prescribed dialysis treatment time ≤ 10%
1 secondary outcome
Tablo Cartridge Life
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No. Only aggregated participant data is planned to be shared at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease (ESRD) and End Stage Renal Disease on Dialysis, run by Outset Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.