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

Completed · Not applicable

Conditions studied: Non-invasive Lipolysis

In brief

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.

Key facts

Study ID

NCT04878172

Run by

Cynosure, Inc.

People needed

9

Starts

2021-03-12

Expected to finish

2021-09-28

Last updated by the study team

2022-04-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 - 55 years old.
• Willing to receive treatments with the TempSure® device and willing to have biopsies taken from a control site and the treatment area (biopsies are collected after the abdominal tissue flap is removed during abdominoplasty surgery)
• Understand and accept obligation not to receive any other procedures on the treatment and control areas throughout the length of the study.
• Understand and accept the obligation and able to be present for all study visits
• Willing to comply with all requirements of the study and able to provide informed consent.

You may not qualify if…

• Pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning to become pregnant prior to the end of the study.
• Currently enrolled in an investigational drug or device trial, or has received an investigational drug or investigational device treatment(s) in the area to be treated (or designated control area) 6 months prior to entering this study (or at the discretion of the Investigator) .
• Cuts, wounds, or infected skin on the area to be treated or designated control area
• On local, oral, or systemic anesthetic agents.
• Condition(s) or circumstance(s) that, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with subject participation.

Where it is running

• Bass Plastic Surgery PLLC — New York, New York, United States
• Aesthetic Pavilion Ambulatory Surgery Center — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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