Status:
COMPLETED
Multi-Center Pilot Study of truSculpt Device
Lead Sponsor:
Cutera Inc.
Conditions:
Bulging
Body Fat
Eligibility:
All Genders
18-65 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.
Key Trial Info
Start Date :
August 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03433430
Start Date
August 17 2017
End Date
March 7 2018
Last Update
September 18 2023
Active Locations (3)
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1
Cutera Research Center
Brisbane, California, United States, 94005
2
Skin Associates of South Florida
Coral Gables, Florida, United States, 33146
3
The Dermatology Institute of DuPage Medical Group
Naperville, Illinois, United States, 60563