Clinical Study to Evaluate the Safety and Efficacy of the Vela100

NCT01026441 | Terminated Phase 4

• 1 other identifier: Vela100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cellulite Reduction; Circumference Reduction

Keywords

Aesthetic

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  End of treatment, at 1 month FU

Study Arms (1)

Treatment for cellulite and circumference reduction

OTHER

All subjects will be treated with the device

Device: Vela100 (Aesthetic)

Interventions

Vela100 (Aesthetic) DEVICE

6 treatments once a week

Treatment for cellulite and circumference reduction

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Suffering from hormonal imbalance which may affect weight or cellulite, as per the Investigator's discretion.
• History of significant lymphatic drainage problems. 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.
• History of keloid scarring or of abnormal wound healing.
• History of being especially prone to bruising.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (2)

Orange Coast Women's Medical Group

Laguna Hills, California, 92653, United States

Location

Kavali Plastic Surgery and Skin Renewal Center

Atlanta, Georgia, 30342, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 5, 2011

Record last verified: 2011-05

Locations

US (2)