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

Lipolysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04881175
• Other study ID #: CYN20-FLEX-HISTO
• Status: Terminated
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: February 25, 2021

Study information

• Verified date: May 2022
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lipolysis

Intervention

Device:
• Non-Invasive Treatment
Single-arm group using the FlexSure Applicator device.

Locations

Country	Name	City	State
United States	New Jersey Plastic Surgery	Montclair	New Jersey
United States	Bass Plastic Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)