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Clinical Study to Evaluate the Safety and Efficacy of the Vela100 | Clinical Trials | Clareo Health

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Clinical Study to Evaluate the Safety and Efficacy of the Vela100

Clinical Study to Evaluate the Safety and Efficacy of the Vela100/eShape Uno Device for Cellulite and Circumference Reduction

NCT01026441•Syneron Medical

View on ClinicalTrials.gov

Summary

This study is intended to test the safety of the Vela100 device when used for treatment for cellulite and circumference temporary reduction.

Eligibility

Age

21 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Informed consent agreement signed by the subject.
•Healthy males or females older than 21 years of age but not older than 60 years of age.
•Fitzpatrick Skin Type I to VI
•Having at least two areas (abdomen, buttocks and thighs) suitable for treatment.
•BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
•Willingness to follow the treatment and follow-up schedule and the post-treatment care.
•Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
•For female of child bearing potential - using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).

Exclusion Criteria

•Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
•Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
•Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
•Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
•Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 9 months of treatment or during the study.
•For post-liposuction areas, the procedure should also not have been performed more than 2 years prior to this study.
•Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
•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.
•Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
•Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
+14 more criteria

Locations (2)

Orange Coast Women's Medical Group

Laguna Hills, California, United States

Kavali Plastic Surgery and Skin Renewal Center

Atlanta, Georgia, United States

Key Dates

Start Date

October 1, 2008

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

May 5, 2011

Enrollment

ESTIMATED participants

Conditions

Cellulite ReductionCircumference Reduction

Interventions

Vela100 (Aesthetic)

DEVICE

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COMPLETEDNA

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TERMINATEDNA

Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference

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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: May 5, 2011Data 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.

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Clinical Study to Evaluate the Safety and Efficacy of the Vela100

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Combined EMS and RF Treatments

Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.

Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference

VelaShape III & UltraShape Power for Thigh Circumference Reduction