NCT04881175

Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis

Histological Study to Assess Safety and Efficacy of a Radiofrequency Device Flexible Applicator for Non-Invasive Lipolysis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect efficacy data on the TempSure FlexSure applicator for fat lipolysis.

Detailed description

Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments every 1-2 weeks on the abdomen or flanks.

Conditions

• Lipolysis

Interventions

Type	Name	Description
DEVICE	Non-Invasive Treatment	Single-arm group using the FlexSure Applicator device.

Timeline

• Start date: 2021-02-09
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2021-05-11
• Last updated: 2022-05-31
• Results posted: 2022-05-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study