Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
NCT01708252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2017-11-24
Summary
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Conditions
- Skin Laxity
Interventions
- DEVICE
-
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Sponsors & Collaborators
-
Ulthera, Inc
lead INDUSTRY
Principal Investigators
-
Steven H Dayan, MD, FACS · DeNova Research
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2012-04-30
- Completion
- 2012-08-31
Countries
- United States
Study Locations
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