CARESCAPE Monitoring Systems ME Study | NCT07024459

Studies
CARESCAPE Monitoring Systems ME Study

NCT07024459

Sponsor

GE Healthcare

Status

Enrolling by invitation

Last Update Posted

Jun 17, 2025Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Surgery, Intensive Care

Interventions

Monitoring

Countries

Finland

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2024Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Mar 31, 2025

First Submission Date that Met QC Criteria

Jun 9, 2025

First Posted Date

Jun 17, 2025Actual

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

Jun 9, 2025

Last Update Posted Date

Jun 17, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol.

Detailed Description

Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation.

In this study it is essential to gain data from different age groups; children, adults, and elderly people since they are targeted population to use the devices in the future. In different age groups, there is e.g., a different physiological factures that may affect the product under development.

Different parameters will be studied under this study protocol. To get real picture of these parameters investigated, it is essential to also collect data from other parameters, e.g., electrocardiogram (ECG), oxygen saturation (SpO2) and carbon dioxide (CO2, including CO2 derived respiration rate (RR)).

The results of this study are intended to be used in product development purposes and as an additional data to support conformity to the general safety and performance requirements of the Medical Device Regulation within device's Clinical Evaluation process. The study described herein is being conducted to collect feedback from the parameters studied, and to collect the parameter raw data from the patients in the hospital units using the investigational devices.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
data collection	Experimental		Device: Monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monitoring	Device	Participants will be monitored with secondary monitor collecting data from parameters under evaluation	data collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical evaluation of the performance and usability	Primary outcome of this study is to conduct clinical evaluation of the performance and usability of the new software and hardware features introduced to the system by collecting data and surveys.	From admission to discharge, maximum of 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Collection of data	The secondary study outcome will be reached when the minimum number of subjects with good raw data quality have been collected and analyzed for product development.	From admission to discharge, maximum of 24 hours

Other Outcomes

Measure	Description	Time Frame
Collection of safety information	Collection of number and type of AEs, SAEs and device issues	From admission to discharge, maximum of 24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
Parameter(s) in scope of the study can be collected

Exclusion Criteria:

Are known to be pregnant;
Are breastfeeding;
Are suffering from infection(s) or immunocompromised patients that require isolation.
Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
PI or designee decision due to subject's health condition

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Espoo	Uusimaa	02740	Finland