Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT05831800
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2023-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals
Sponsor:
Mode Sensors AS
Organization:
Study Overview
Official Title:
Assessing Hydration Status With a Wearable Bioimpedance Sensor in Elderly Individuals - A Prospective Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
RECRUITING
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:
HELD
Brief Summary:
This is a single-arm prospective study, investigating the feasibility, usability, and safety of a wearable bioimpedance sensor in elderly individuals. The sensor is applied on the upper back of the subject, and will be replaced once weekly. The study will include four phases, each interspersed by an interim analysis. Each phase will have a duration of four weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: