Multi-Center Pilot Study of truSculpt Device

NCT03433430 | Completed Results FDA Device

• 1 other identifier: C-17-TS16
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Bulging; Body Fat

Outcome Measures

Primary Outcomes (1)

• Body Fat Assessment by Investigator

  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

  12 weeks post final treatment

Study Arms (1)

truSculpt

OTHER

truSculpt treatment

Device: truSculpt

Interventions

truSculpt DEVICE

Subjects will receive utreatments and will be followed at 12 weeks post final treatment.

truSculpt

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of any disease or condition that could impair wound healing.
• History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing.
• 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.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (3)

Cutera Research Center

Brisbane, California, 94005, United States

Location

Skin Associates of South Florida

Coral Gables, Florida, 33146, United States

Location

The Dermatology Institute of DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-656-9612

Study Officials

• Stephen Ronan, MD

  Cutera Research Center

  PRINCIPAL INVESTIGATOR

• Ashish Bhatia, MD

  The Dermatology Institute of DuPage Medical Group

  PRINCIPAL INVESTIGATOR

• Joely Kaufman, MD, FAAD

  Skin Associates of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 14, 2018
• Study Start: August 17, 2017
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-09

Locations

US (3)