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ACTIVE NOT RECRUITING
NCT06471933
NA

Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles

Sponsor: Nordberg Medical AB

View on ClinicalTrials.gov

Summary

The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine. The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds. Participants will: Receive 3 rounds of treatment and will be followed up for a total of 2 years.

Official title: A Prospective, Single-Arm, Interventional, Multicenter, Post-Market Clinical Follow-up (PMCF) Investigation to Evaluate the Performance and Safety of Injectable Poly-LLactic Acid Dermal Filler for the Treatment of Nasolabial Fold Wrinkles

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2024-07-24

Completion Date

2027-06

Last Updated

2025-08-26

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Juläine

Dermal filler (PLLA)

Locations (2)

Ribé clinic

Barcelona, Spain

The Faculty

Stockholm, Sweden