Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT06816069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening
Sponsor:
CLASSYS Inc.
Organization:
Study Overview
Official Title:
Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
Objective:
The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.
Research Questions:
1. Does the VOLNEWMER device improve skin elasticity?
2. Is the safety profile of the VOLNEWMER device acceptable?
Subject Procedures:
Subjects will:
* Receive a single treatment session using the VOLNEWMER device.
* Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.
The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.
Research Questions:
1. Does the VOLNEWMER device improve skin elasticity?
2. Is the safety profile of the VOLNEWMER device acceptable?
Subject Procedures:
Subjects will:
* Receive a single treatment session using the VOLNEWMER device.
* Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.
The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
Detailed Description:
None
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?: