Clinical trial NCT04881175: Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis
Official title: Histological Study to Assess Safety and Efficacy of a Radiofrequency Device Flexible Applicator for Non-Invasive Lipolysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lipolysis
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment
timeFrame: immediately post treatment (only 1 treatment was conducted)
measure: Count of Samples That Showed an Inflammatory Immune Response Vs. Baseline
timeFrame: Baseline, immediately post treatment (only 1 treatment was conducted)
Secondary outcomes:
Other outcomes:
Locations:
city: Montclair
country: United States
facility: New Jersey Plastic Surgery
state: New Jersey
city: New York
country: United States
facility: Bass Plastic Surgery
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
References:
citation: 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.