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VelaShape III & UltraShape Power for Thigh Circumference Reduction | Clinical Trials | Clareo Health

COMPLETEDNA

VelaShape III & UltraShape Power for Thigh Circumference Reduction

Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction

NCT03430245•Syneron Medical

Summary

Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.

Detailed Description

Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol. Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Signed informed consent to participate in the study.
•2. Female and male subjects, 18 and 60 years of age at the time of enrollment.
•3. Fitzpatrick Skin Type I to VI.
•4. Fat thickness of at least 1.5 cm (measured by calibrated caliper).
•5. BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
•6. Female subjects must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
•7. In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with child-bearing potential (e.g. not menopausal).
•8. General good health confirmed by medical history and skin examination of the treated area.
•9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
•10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
+1 more criteria

Exclusion Criteria

•1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
•2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
•3. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
•4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
•5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
•6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
•7. Previous body contouring procedures in the treatment area within 12 months.
•8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
•9. Known photosensitivity.
•10. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
+12 more criteria

Locations (1)

Skin Laser & Surgery Specialist of NY/NJ

Hackensack, New Jersey, United States

Key Dates

Start Date

February 19, 2018

Primary Completion Date

May 30, 2019

Completion Date

July 3, 2019

Last Updated

January 9, 2020

Enrollment

ACTUAL participants

Conditions

Circumference Reduction

Interventions

VelaShape III

DEVICE

UltraShape Power

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.