Detection of Minor Changes in Fluid Volume or Tonicity in... | NCT04937491

Studies
Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.

NCT04937491

Sponsor

Mode Sensors AS

Status

Suspended

Last Update Posted

Jul 12, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Healthy Nutrition

Interventions

New medical device (ReBalans)

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to covid-19

Expanded Access Info

Start Date

May 20, 2021Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

May 31, 2023Estimated

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

Jul 9, 2022

Last Update Posted Date

Jul 12, 2022Actual

Name	Class
University of Tromso	OTHER

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

This study is aimed at detecting minor changes in hydration volume and tonicity. We will use healthy students of both sexes who will ingest fluids and nutrition that should lead to specific changes in both intracellular and extracellular volumes. The protocol is based on laboratory exercises previously carried out at The Arctic University of Norway (UiT).

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteers		Adult healthy volunteers (students). Intervention 1: Intake of water (2% of body weight) Intervention 2: Intake of sports drink (2% of body weight) Intervention 3: Intake of soya saus (salt): 10 ml (equal to 8 g salt) Intervention 4: Intake of 90 g sugar (jelly figures)	Device: New medical device (ReBalans)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
New medical device (ReBalans)	Device	Body worn, battery powered bioimpedance measuring patch device.	Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to detect tonicity or volume change	Accurately depict each of the four interventions with a sensitivity better than 0.9.	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Healthy volunteer

Exclusion Criteria:

Kidney disease,
neurological,
heart or endocrine disease,
hypertension.
Eating disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult healthy volunteers (students), 20 years or older.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arctic University of Norway		Tromsø		9019	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided