Trials / Completed
CompletedNCT04616898
Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty
Analysis of the Performance of 1060 nm Diode Laser and Radiofrequency Intended for Fat Reduction Prior to Abdominoplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Venus Concept · Industry
- Sex
- All
- Age
- 21 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency to be analyzed through histological and molecular analysis.
Detailed description
The Primary Objectives of this protocol are to evaluate the safety and efficacy of treatment with 1060nm diode laser and radio frequency for use in aesthetic dermatological procedures requiring the ablation, excision, incision, or coagulation of soft tissue. Efficacy will be analyzed through histological and molecular analysis. Safety will be analyzed by monitoring the occurrence of any adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Venus Bliss | The Venus Bliss™ system is an aesthetic medical device designed to non-invasively reduce subcutaneous adipose tissue of the abdominal area and flanks. It is intended for use in individuals with a Body Mass Index (BMI) of 30 or less. The device consists of an external treatment component and an internal control component. The treatment console is a 1060nm diode laser applicator and a radio frequency applicator. In addition, a Bliss Belt is provided with the system to properly secure one or more applicators to the patient's body during treatment. Finally, the touchscreen monitor is used by the clinician to control the setting display on the main console. It also keeps the clinician informed of the device's status and operating parameters. |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2023-11-27
- Completion
- 2023-11-27
- First posted
- 2020-11-05
- Last updated
- 2024-08-21
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04616898. Inclusion in this directory is not an endorsement.