Multi-Center Pilot Study of truSculpt Device

Completed · Not applicable

Conditions studied: Bulging, Body Fat

In brief

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

Key facts

Study ID

NCT03433430

Run by

Cutera Inc.

People needed

9

Starts

2017-08-17

Expected to finish

2018-03-07

Last updated by the study team

2023-09-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.