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

Stopped early · Not applicable

Conditions studied: Lipolysis

In brief

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

Key facts

Study ID

NCT04881175

Run by

Cynosure, Inc.

People needed

3

Starts

2021-02-09

Expected to finish

2021-02-25

Last updated by the study team

2022-05-31

Who can join

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

You may qualify if…

• A healthy male or female between the age of 18 - 55 years old.
• Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

You may not qualify if…

• Is 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 a pregnancy during the study.
• The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
• The subject has a cut, wound, or infected skin on the area to be treated.
• The subject is on local, oral, or systemic anesthetic agents.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.

Where it is running

• New Jersey Plastic Surgery — Montclair, New Jersey, United States
• Bass Plastic Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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