Suspected or Diagnosed Endotoxemia Casued by Gram-negative BacteriaNCT05260099
Remove LPS Registry
An observational study of Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria, run by Alteco Medical AB.
Trial summary
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
- What is being tested?
- LPS Adsorber
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Jul 2023
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected or diagnosed sepsis caused by gram-negative bacteria.
Who may be able to join
- Weight > 30 kilos
- Specific sub-registry criteria are possible.
Who cannot join
- None
About this study
Official title: Post Market Clinical Follow up (PMCF) Medical Device (MD) Registry of the Alteco® LPS Adsorber to Remove Lipopolysaccharide (LPS) in Patients With Suspected Endotoxemia, With Severe Symptom(s)/Complication(s) and Their Stabilization Outcomes: REMOVE LPS Registry
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
- Being tested
- LPS Adsorber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPS AdsorberDevice
LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Patients not treated with LPS Adsorber | |
| Prospective | Patients treated with LPS Adsorber Receives: Device: LPS Adsorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.
Measured: 30 days
Secondary outcomes (2)
Secondary Outcomes will be to document the change in a patient's symptoms of infection over time.
Measured: 30 days
Rate of complaints and incidents related to the medical device during the whole registry.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Company decision not to start study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected or Diagnosed Endotoxemia Casued by Gram-negative BacteriaStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Alteco Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260099
- Sponsor's protocol ID
- Remove LPS Registry
- Status last verified
- Dec 2022
- First submitted
- 18 Feb 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow up (PMCF) Medical Device (MD) Registry of the Alteco® LPS Adsorber to Remove Lipopolysaccharide (LPS) in Patients With Suspected Endotoxemia, With Severe Symptom(s)/Complication(s) and Their Stabilization Outcomes: REMOVE LPS Registry
- ClinicalTrials.gov ID
- NCT05260099
- Acronym / sponsor ID
- Remove LPS Registry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company decision not to start study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alteco Medical ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –Patients not treated with LPS Adsorber |
| Prospective | – | Device: LPS AdsorberPatients treated with LPS Adsorber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or diagnosed sepsis caused by gram-negative bacteria.
Key inclusion criteria (2 listed)
- Weight > 30 kilos
- Specific sub-registry criteria are possible.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LPS AdsorberLPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria. | Device | Prospective |
Primary outcome
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.
Time frame: 30 days
2 secondary outcomes
Secondary Outcomes will be to document the change in a patient's symptoms of infection over time.
Time frame: 30 days
Rate of complaints and incidents related to the medical device during the whole registry.
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria, run by Alteco Medical AB.
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: withdrawn, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment. (time frame: 30 days). 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 20 Dec 2022.