Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01519934
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2011-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Study to Evaluate the Effectiveness of the Ulthera System
Sponsor:
Ulthera, Inc
Organization:
Study Overview
Official Title:
Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck
Status:
COMPLETED
Status Verified Date:
2017-11
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:
Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.
Detailed Description:
This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.
Study Oversight
Has Oversight DMC:
False
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?: