Safety and Efficacy of Combined EMS and RF Treatments (NCT04124419) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Combined EMS and RF Treatments
United States20 participantsStarted 2019-07-19
Plain-language summary
The objective of this trial is to evaluate the safety and efficacy of the Evolve device utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction and skin tightening
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Signed informed consent to participate in the study.
* Female and male subjects,18 - 65 years of age at the time of enrolment
* BMI≤ 30
* If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
* In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
* General good health confirmed by medical history and skin examination of the treated area.
* Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
* The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Exclusion Criteria:
* \- Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
* Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
* Intra-dermal or superficial sub-dermal areas that have been injected with HA/collagen/fat injections or …
What they're measuring
1
Change in Circumference Reduction
Timeframe: Baseline to 6 months following last treatment session