Multi-Center Pilot Study of truSculpt Device

Body Fat Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433430
• Other study ID #: C-17-TS16
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: March 7, 2018

Study information

• Verified date: September 2023
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Fat
• Bulging

Intervention

Device:
• truSculpt
Subjects will receive utreatments and will be followed at 12 weeks post final treatment.

Locations

Country	Name	City	State
United States	Cutera Research Center	Brisbane	California
United States	Skin Associates of South Florida	Coral Gables	Florida
United States	The Dermatology Institute of DuPage Medical Group	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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