Profound Dermal and SubQ Cartridges for the Treatment of Cellulite
NCT03078647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2019-06-25
Summary
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Conditions
- Cellulite
Interventions
- DEVICE
-
Profound
The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (RF) energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
Sponsors & Collaborators
-
Syneron Medical
lead INDUSTRY
Principal Investigators
-
Girish Munavalli, MD · Laser & Vein Specialists of the Carolinas
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-13
- Primary Completion
- 2018-11-02
- Completion
- 2019-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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