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

Histological Study to Assess Safety and Efficacy of a Radiofrequency Device Flexible Applicator for Non-Invasive Lipolysis

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

Study Overview

• Status: Terminated
• Conditions: Lipolysis
• Intervention / Treatment: Device: Non-Invasive Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery
  • New York
    • New York, New York, United States, 10065
      • Bass Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FlexSure Applicator; The TempSure FlexSure applicator will be used on the abdomen or flanks.	Device: Non-Invasive Treatment; Single-arm group using the FlexSure Applicator device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment	Photographs of the histological samples before and after the treatment (only one treatment occurred) will be examined for adipocyte necrosis. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H&E stain). To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in adipocyte necrosis will be reported.	immediately post treatment (only 1 treatment was conducted)
Count of Samples That Showed an Inflammatory Immune Response Vs. Baseline	Photographs of the histological samples before and after the last treatment will be examined for an inflammatory immune response. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H&E stain) To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in an inflammatory immune response will be reported.	Baseline, immediately post treatment (only 1 treatment was conducted)

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Jennifer Civiok, Cynosure, Inc.

Publications and helpful links

General Publications

• Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CYN20-FLEX-HISTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes