Trials / Completed
CompletedNCT05624216
Radiofrequency and Targeted Pressure Energy for Cellulite Reduction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- BTL Industries Ltd. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.
Detailed description
This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device. At the baseline visit subject's weight will be recorded, together with hip and thigh circumference. In addition, photographs of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered in 2-4 weeks. The applicator will be applied over the treatment area. At the last therapy visit, the subject's weight will be recorded, together with hip and thigh circumference. Photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Safety measures will include documentation of adverse events (AE). Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BTL-084 | Radiofrequency and targeted pressure energy devices for the treatment of cellulite |
Timeline
- Start date
- 2019-07-30
- Primary completion
- 2020-04-08
- Completion
- 2021-10-25
- First posted
- 2022-11-22
- Last updated
- 2022-11-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05624216. Inclusion in this directory is not an endorsement.