Trials / Completed
CompletedNCT03078647
Profound Dermal and SubQ Cartridges for the Treatment of Cellulite
Clinical Study to Evaluate the Safety and Efficacy Performance of the Profound System Using the Dermal and Sub-dermal (SubQ) Cartridges for the Treatment of Cellulite
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Syneron Medical · Industry
- Sex
- Female
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.
Detailed description
Up to 60 healthy female volunteers, seeking cellulite treatment, 18 to 60 years of age from up to 3 investigational sites. Prospective, open-label, baseline-controlled, two arms, randomized, clinical study to evaluate the Profound device using the Dermal and SubQ Cartridges for minimally-invasive treatment of the upper thighs and buttocks cellulite appearance. The treatment areas of the study subjects will be divided into two arms: 1. Arm 1 - the upper thigh/buttock on the left or right side of the body will undergo a single Profound treatment utilizing the Dermal and SubQ Cartridges 2. Arm 2 - the contralateral upper thigh/buttock side of the body will undergo a single Profound treatment utilizing the SubQ Cartridge only. Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-09-13
- Primary completion
- 2018-11-02
- Completion
- 2019-01-31
- First posted
- 2017-03-13
- Last updated
- 2019-06-25
- Results posted
- 2019-06-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03078647. Inclusion in this directory is not an endorsement.