Status:
TERMINATED
Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis
Lead Sponsor:
Cynosure, Inc.
Conditions:
Lipolysis
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04881175
Start Date
February 9 2021
End Date
February 25 2021
Last Update
May 31 2022
Active Locations (2)
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1
New Jersey Plastic Surgery
Montclair, New Jersey, United States, 07042
2
Bass Plastic Surgery
New York, New York, United States, 10065