Biomarkers in Dermal Interstitial Fluid for Early Diagnos... | NCT06632353

Studies
Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases

NCT06632353

Sponsor

Ascilion AB

Status

Active, not recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Not provided

Countries

Sweden

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2024Actual

Primary Completion Date

Nov 5, 2025Actual

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Oct 7, 2024

First Submission Date that Met QC Criteria

Oct 7, 2024

First Posted Date

Oct 9, 2024Actual

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

Jan 23, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Sampling of dISF and blood plasma for qualitative measurements.

Detailed Description

Sampling of dISF will be performed to investigate biomarkers in dISF for early diagnosis and follow-up of cardiovascular diseases.

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
Group 1		Cardiovascular diseases
Group 2		Reference

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of dISF biomarker	Presence or not	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Group 1: Chronic heart failure with stable therapy. NYHA classification II, III and IV. Age > 60 years. Group 2: Age 18-40 years.

Exclusion criteria:

Participating in another clinical investigation which may affect the study outcome according to clinical judgement.
Previous use of sampling system used.
Pregnancy or lactating.
Any disease or condition that may be affected.
Individuals who lack the ability to fully consent to participate in the study.
Severe skin injury.
Tattoo or piercing close to sampling area.
Group 1: All forms of emergency care.
Group 1: Non-stable therapy.
Group 1: Sepsis.
Group 1: BMI > 30kg/m2.
Group 1: Age > 84 years.
Group 2: Known heart or vascular disease.
Group 2: Diabetes.
Group 2: Kidney disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers and subjects recruited at hospital

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Will probably be published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided