Trials / Completed
CompletedNCT04569253
Multi-Center Pivotal Study of Radiofrequency Device
Clinical Study to Assess the Safety and Efficacy of the Tempsure® Firm for Non-invasive Lipolysis of the Flanks.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Cynosure, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the flank (love handle) area.
Detailed description
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. A maximum of 55 subjects will be enrolled at up to 6 study centers. Subjects will receive up to 5 treatments with the TempSure® Firm on one flank. The other flank will be left untreated to serve a control. Subject will be required to return for follow-up visits at 6 weeks and at 12 weeks after the subject's final treatment. All subjects will receive a phone call 1 week (1-10 days) post each treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TempSure | Non-invasive radiofrequency treatments |
Timeline
- Start date
- 2020-07-28
- Primary completion
- 2021-03-26
- Completion
- 2021-03-26
- First posted
- 2020-09-29
- Last updated
- 2022-06-14
- Results posted
- 2022-06-14
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04569253. Inclusion in this directory is not an endorsement.