NCT04878172

Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (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 safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.

Detailed description

Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.

Conditions

• Non-invasive Lipolysis

Interventions

Type	Name	Description
DEVICE	TempSure Firm	The TempSure firm will be used on the abdomen for non-invasive lipolysis.

Timeline

• Start date: 2021-03-12
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2021-05-07
• Last updated: 2022-04-21
• Results posted: 2022-04-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study