Clinical trial NCT03433430: Multi-Center Pilot Study of truSculpt Device
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulging
Body Fat
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

1. Subject must be able to read, understand and sign the Informed Consent Form.
2. Female or Male, 18 to 65 years of age (inclusive).
3. Subject has visible fat bulges in the area to be treated.
4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period.
6. Subject must adhere to the follow-up schedule and study instructions.
7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study.
8. 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.
9. 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:

1. Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period.
2. Any type of prior cosmetic treatment to the target area within 6 months of study participation.
3. Any prior invasive cosmetic surgery to the target area, such as liposuction.
4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
5. Has metal implant(s) within the body, such as artificial heart valves.
6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
7. History of any disease or condition that could impair wound healing.
8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion.
10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
11. 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.

Primary outcomes:
measure: Body Fat Assessment by Investigator
timeFrame: 12 weeks post final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Cutera Research Center
state: California
city: Coral Gables
country: United States
facility: Skin Associates of South Florida
state: Florida
city: Naperville
country: United States
facility: The Dermatology Institute of DuPage Medical Group
state: Illinois
Study officials:
affiliation: Cutera Research Center
name: Stephen Ronan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Dermatology Institute of DuPage Medical Group
name: Ashish Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Associates of South Florida
name: Joely Kaufman, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References: