Clinical trial NCT04878172: Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
Official title: Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Lipolysis
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 4 different arms, each with different time frames based on thei subjects' availability. Each group uses the same device and treatment parameters, with the only difference being when follow up measures are taken.
Primary purpose: TREATMENT

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 handpieces for non-invasive lipolysis.

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 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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.

Primary outcomes:
measure: Histology of Biopsy
timeFrame: within 24 hours post treatment
measure: Histology of Biopsy
timeFrame: within 10 days (+/- 3 days) post treatment
measure: Histology of Biopsy
timeFrame: within 20 days (+/- 3 days) post treatment
measure: Histology of Biopsy
timeFrame: within 30 days (+/- 7 days) post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Bass Plastic Surgery PLLC
state: New York
city: Staten Island
country: United States
facility: Aesthetic Pavilion Ambulatory Surgery Center
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.