Remove LPS Registry
Sponsor
Alteco Medical AB (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05260099
Collaborator
(none)
120
8
Study Details
Study Description
Brief 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. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
120 participants
Observational Model:
Other
Time Perspective:
Other
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
Anticipated Study Start Date
:
Nov 1, 2022
Anticipated Primary Completion Date
:
Nov 1, 2022
Anticipated Study Completion Date
:
Jul 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Retrospective Patients not treated with LPS Adsorber |
|
| Prospective Patients treated with LPS Adsorber |
Device: LPS Adsorber
LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment. [30 days]
Secondary Outcome Measures
- Secondary Outcomes will be to document the change in a patient's symptoms of infection over time. [30 days]
- Rate of complaints and incidents related to the medical device during the whole registry. [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Weight > 30 kilos
Specific sub-registry criteria are possible.
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alteco Medical AB
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Alteco Medical AB
ClinicalTrials.gov Identifier:
NCT05260099
Other Study ID Numbers:
- Remove LPS Registry
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: