N/A
N=9
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
Non-invasive Lipolysis
Bottom Line
View on ClinicalTrials.gov: NCT04878172 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Histology of Biopsy — 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TempSure Firm (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histology of Biopsy |
3; 3 | — |
| PRIMARY Histology of Biopsy |
3; 3 | — |
| PRIMARY Histology of Biopsy |
3; 3 | — |
| PRIMARY Histology of Biopsy |
3; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04878172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.