This is an Exploratory Multi-center, Pilot Study to Evaluate the Safety, Efficacy and Ergonomics of Cutera truSculpt Device. Subjects May Receive up to Three Treatments and Will be Followed at 12 Weeks Post the First and Final Treatment.

Cutera Inc.3 sites in 1 country9 target enrollmentAugust 17, 2017

ConditionsBulging Body Fat

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bulging
Sponsor: Cutera Inc.
Enrollment: 9
Locations: 3
Primary Endpoint: Body Fat Assessment by Investigator
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device

Detailed Description

This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects will receive treatments and will be followed at 12 weeks post final treatment.

Registry

clinicaltrials.gov

Start Date

August 17, 2017

End Date

March 7, 2018

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cutera Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be able to read, understand and sign the Informed Consent Form.
•Female or Male, 18 to 65 years of age (inclusive).
•Subject has visible fat bulges in the area to be treated.
•Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
•Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
•Subject must adhere to the follow-up schedule and study instructions.
•Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
•Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
•For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

Exclusion Criteria

•Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period.
•Any type of prior cosmetic treatment to the target area within 6 months of study participation.
•Any prior invasive cosmetic surgery to the target area, such as liposuction.
•Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
•Has metal implant(s) within the body, such as artificial heart valves.
•Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
•History of any disease or condition that could impair wound healing.
•History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
•Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
•Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.

Outcomes

Primary Outcomes

Body Fat Assessment by Investigator

Time Frame: 12 weeks post final treatment

Degree of Improvement in body fat as assessed by Investigator using the Global Aesthetic Improvement Scale (GAIS:) +4=Very Significant Improvement, +3=Significant Improvement, +2=Moderate Improvement, +1=Mild Improvement, and 0=No Change Higher scores indicate better outcomes