Explorative Study on a New Device' Ability to Register Hy... | NCT04937465

Studies
Explorative Study on a New Device' Ability to Register Hydration Change in Elderly Subjects During Rehabilitation.

NCT04937465

Sponsor

Mode Sensors AS

Status

Withdrawn

Last Update Posted

Nov 19, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Dehydrated, Water-Electrolyte Imbalance, Malnutrition

Interventions

No intervention done

Countries

Norway

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

Jun 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped because of covid-19 restrictions imposed for the next 9 months

Expanded Access Info

Start Date

Nov 1, 2021Estimated

Primary Completion Date

Oct 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jun 16, 2021

First Submission Date that Met QC Criteria

Jun 16, 2021

First Posted Date

Jun 24, 2021Actual

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

Nov 11, 2021

Last Update Posted Date

Nov 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Mode Sensors ASINDUSTRY

Collaborators

Name	Class
Norwegian Computing Center, Oslo Norway	UNKNOWN
Lilleborg helsehus, Oslo, Norway	UNKNOWN
Nidarvoll helsehus, Trondheim, Norway	UNKNOWN
Ryen helsehus, Trondheim, Norway

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly		Elderly (> 70 yrs) eligible for a short term rehabilitation	Other: No intervention done

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention done	Other	No intervention was done. This was an observational study.	Elderly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hydration state	Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80	During rehabilitation period (3 - 5 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elderly patients eligible for rehabilitation

Exclusion Criteria:

Subjects with end stage cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly people eligible for short term (3 - 5 weeks) rehabilitation because of either (i) malnutrition and or dehydration, or (ii) overhydration from heart failure treatment.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Lilleborg helsehus		Oslo		0569	Norway
Ryen helsehus

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

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration
D014883	Water-Electrolyte Imbalance
D044342	Malnutrition

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided