Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT03863834
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of RFAL of Breast Envelope and NAC Position
Sponsor:
InMode MD Ltd.
Organization:
Study Overview
Official Title:
Clinical Evaluation of Safety and Efficacy of Radio-Frequency Assisted Lipolysis (RFAL) of Breast Envelope and Nipple-Areolar Complex (NAC) Position
Status:
COMPLETED
Status Verified Date:
2021-02
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:
This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.
Detailed Description:
The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential imaging system (Canfield, NJ)
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?: