Remove LPS Registry | NCT05260099

Studies
Remove LPS Registry

NCT05260099

Sponsor

Alteco Medical AB

Status

Withdrawn

Last Update Posted

Dec 20, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria

Interventions

LPS Adsorber

Countries

Not provided

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision not to start study

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Nov 2022Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Feb 18, 2022

First Submission Date that Met QC Criteria

Feb 18, 2022

First Posted Date

Mar 2, 2022Actual

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

Dec 16, 2022

Last Update Posted Date

Dec 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospective		Patients not treated with LPS Adsorber
Prospective		Patients treated with LPS Adsorber	Device: LPS Adsorber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LPS Adsorber	Device	LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.	Prospective

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.		30 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weight > 30 kilos

Specific sub-registry criteria are possible.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected or diagnosed sepsis caused by gram-negative bacteria.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided