NCT06322043

Brief Summary

Adipearl is an injectable filler intended to be injected subcutaneously.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

March 13, 2024

Last Update Submit

September 18, 2025

Conditions

Face Volume Deficiency

Outcome Measures

Primary Outcomes (1)

  • Safety of Investigational Medical Device

    Collection of Injection Site Reactions and Adverse Events during the study.

    6-Months

Study Arms (1)

Volume correction with Investigational Device

EXPERIMENTAL

Subjects will be injected subcutaneously with the Investigational Device to correct volume deficiencies.

Device: Adipearl

Interventions

AdipearlDEVICE

Injection of the investigational device in subcutaneous tissue.

Volume correction with Investigational Device

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summit Clinic

Crans-Montana, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

March 26, 2024

Primary Completion

June 21, 2025

Study Completion

October 30, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)