Trials / Completed
CompletedNCT04881149
Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Cynosure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.
Detailed description
Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TempSure treatment | Self-controlled, single-arm study using the TempSure device. |
Timeline
- Start date
- 2021-02-12
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
- First posted
- 2021-05-11
- Last updated
- 2022-06-01
- Results posted
- 2022-06-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04881149. Inclusion in this directory is not an endorsement.