CARESCAPE Monitoring Systems ME Study

NCT07024459 | Enrolling By Invitation

• 1 other identifier: 11897644380
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery, Intensive Care

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Collection of data

  From admission to discharge, maximum of 24 hours

Other Outcomes (1)

• Collection of safety information

  From admission to discharge, maximum of 24 hours

Study Arms (1)

data collection

EXPERIMENTAL

Device: Monitoring

Interventions

Monitoring DEVICE

Participants will be monitored with secondary monitor collecting data from parameters under evaluation

data collection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Helsinki University Hospital

Espoo, Uusimaa, 02740, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: June 17, 2025
• Study Start: June 13, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-03

Locations

FI (1)