Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053710
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-09-19
Brief Title:
Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor
Sponsor:
Mode Sensors AS
Organization:
Mode Sensors AS
Study Overview
Official Title:
Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems DELOS
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELOS
Brief Summary:
The investigation is a prospective cohort study where two patient groups will be monitored by a wearable bioimpedance sensor during their scheduled treatment The overall objective is to assess the bioimpedance sensors ability to detect local and systemic fluid accumulation
Sub-investigation A will investigate the ability of the device to detect fluid accumulation in patients with stable chronic kidney disease undergoing regular and planned hemodialysis
Sub-investigation B will investigate the ability of the device to track hydration status in patients scheduled for an intensive dialysis treatment regime due to severe overhydration
Sub-investigation A will investigate the ability of the device to detect fluid accumulation in patients with stable chronic kidney disease undergoing regular and planned hemodialysis
Sub-investigation B will investigate the ability of the device to track hydration status in patients scheduled for an intensive dialysis treatment regime due to severe overhydration
Detailed Description:
In Sub-investigation A patients will be monitored for at least 10 consecutive dialysis sessions and for a minimum of 3 weeks Patients will wear two sensors upper back and lower anterior leg
In Sub-investigation B patients will use the device throughout their whole treatment period and for most patients this will correspond to 2-6 dialysis treatments over 3 to 10 days Patients will wear four patches upper back lateral thorax anterior thigh and lower anterior leg
In Sub-investigation B patients will use the device throughout their whole treatment period and for most patients this will correspond to 2-6 dialysis treatments over 3 to 10 days Patients will wear four patches upper back lateral thorax anterior thigh and lower anterior leg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None