Status:
COMPLETED
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
Lead Sponsor:
Cynosure, Inc.
Conditions:
Non-invasive 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 safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm ha...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04878172
Start Date
March 12 2021
End Date
September 28 2021
Last Update
April 21 2022
Active Locations (2)
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1
Bass Plastic Surgery PLLC
New York, New York, United States, 10065
2
Aesthetic Pavilion Ambulatory Surgery Center
Staten Island, New York, United States, 10306