Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT06471933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Sponsor:
Nordberg Medical AB
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: