Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06157567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2023-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Sponsor:
Candela Corporation
Organization:
Study Overview
Official Title:
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
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:
This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.
Detailed Description:
The Profound Matrix system is a multipurpose (3-in-1) radiofrequency (RF) platform. The clinical study is to evaluate the safety and performance of the Profound Matrix system with Sublime applicator, RF applicator and Matrix Pro applicator for aesthetic treatments including its cleared indications of wrinkles, acne scars, striae, and electrocoagulation and hemostasis. The Sublime and Sublative RF applicators are equivalent to those on the European conformity (CE) marked eLos, eTwo, eMatrix device family. The Matrix Pro applicator utilizes micro-needling technology and is new feature of the Profound Matrix system. The Profound Matrix system, including the Matrix Pro applicator are currently cleared for use in the US under FDA 510k K211217. This study aims to evaluate additional indications for treatment through the electrocoagulation and hemostasis mechanism of action for dermal remodeling and improvement in skin conditions to provide study subjects with a safe and effective alternative treatment that can be performed with minimal risks and decreased downtime. Eligible subjects would be healthy adult volunteers between 18 to 75 years of age seeking clinical treatment for indications as listed above. The research is sponsored by Candela Corporation and planned to be conducted at up to 20 sites globally. From the first subject enrollment to the last subject follow-up, the expected total duration is up to 5 years across all sites. The participants will undergo informed consent, screening and enrollment, treatments for the indication to be treated, and follow-up visits at no cost. The data from this research will assist Candela in optimizing treatment parameters, treatment guidelines, providing input to clinical education and marketing material, and support the research and development of micro-needling technology alongside energy-based devices.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: