Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT01368835
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2011-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue
Sponsor:
Ulthera, Inc
Organization:
Study Overview
Official Title:
Evaluation of the Ulthera™ System For Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity
Status:
COMPLETED
Status Verified Date:
2014-01
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 clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin
Detailed Description:
The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.
The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.
The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: