Trials / Completed
CompletedNCT03430245
VelaShape III & UltraShape Power for Thigh Circumference Reduction
Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Syneron Medical · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
Detailed description
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol. Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VelaShape III | The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum. |
| DEVICE | UltraShape Power | The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action. |
Timeline
- Start date
- 2018-02-19
- Primary completion
- 2019-05-30
- Completion
- 2019-07-03
- First posted
- 2018-02-12
- Last updated
- 2020-01-09
- Results posted
- 2019-12-26
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03430245. Inclusion in this directory is not an endorsement.