Multi-Center Pilot Study of truSculpt Device

NCT ID: NCT03433430

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-17
• Study Completion Date: 2018-03-07

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.

Conditions

Bulging; Body Fat

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

truSculpt

truSculpt treatment

Group Type: OTHER

truSculpt

Intervention Type: DEVICE

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

Interventions

truSculpt

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Ronan, MD

Role: PRINCIPAL_INVESTIGATOR

Cutera Research Center

Ashish Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

The Dermatology Institute of DuPage Medical Group

Joely Kaufman, MD, FAAD

Role: PRINCIPAL_INVESTIGATOR

Skin Associates of South Florida

Locations

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, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

C-17-TS16

Identifier Type: -

Identifier Source: org_study_id