Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-29 @ 11:44 AM
Study NCT ID:
NCT05674292
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2022-12-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
Sponsor:
Erchonia Corporation
Organization:
Study Overview
Official Title:
An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
Status:
COMPLETED
Status Verified Date:
2023-08
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 purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.
Detailed Description:
The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: