Clinical Investigation Evaluating the Safety and Feasibil... | NCT06034522

Studies
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

NCT06034522

Sponsor

Volumina Medical S.A.

Status

Active, not recruiting

Last Update Posted

Sep 23, 2025Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Mid-face Volume Deficiency

Interventions

Adipearl

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

Sep 2025

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

Nov 25, 2023Actual

Primary Completion Date

Nov 2025Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Aug 21, 2023

First Submission Date that Met QC Criteria

Sep 5, 2023

First Posted Date

Sep 13, 2023Actual

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

Sep 18, 2025

Last Update Posted Date

Sep 23, 2025Actual

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

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Face correction with Investigational device	Experimental	Subjects will be injected with the investigational device in the face.	Device: Adipearl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adipearl	Device	Injection of the investigational device in the face.	Face correction with Investigational device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of Investigational Medical Device	Collection of Injection Site Reactions and Adverse Events during the study.	Up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject having given freely and expressly informed consent;
Subject deemed by the Investigator to be medically fit for injection of the product;
Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria:

Pregnant or nursing woman or planning a pregnancy during the study.
Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
Subject participating to another research study.
Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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