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VelaShape III & UltraShape Power for Thigh Circumference Reduction

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ClinicalTrials.gov Identifier: NCT03430245
Recruitment Status : Active, not recruiting
First Posted : February 12, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Circumference Reduction Device: VelaShape III Device: UltraShape Power Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Arm Intervention/treatment
Experimental: VelaShape III & UltraShape Power
VelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment.
Device: VelaShape III

The VelaShape III, the newest generation VelaShape, is a device based on the CE-cleared VelaShape II and FDA-cleared Transcend device (K120510). All devices combine controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum. The VelaShape III device is indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs and abdomen circumference.

The VelaShape III device has 150W RF energy.


Device: UltraShape Power
The newest generation UltraShape device, UltraShape Power, includes a small transducer (U-Sculpt Power), and is FDA-cleared (K170370) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.




Primary Outcome Measures :
  1. Circumference reduction in the thighs at the 12-week follow-up compared to baseline measurements [ Time Frame: At 12 weeks after the third treatment (week 16) for each subject ]
    Circumference reduction post combined VelaShape III and UltraShape Power treatments


Secondary Outcome Measures :
  1. Circumference reduction in the thighs after each treatment and at follow-ups compared to baseline [ Time Frame: At 2, 4, 8, 12 and 16 weeks for each subject ]
    Circumference reduction post combined VelaShape III and UltraShape Power treatments

  2. Investigator satisfaction [ Time Frame: At 8, 12 and 16 weeks for each subject ]
    Investigator satisfaction assessment will be performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very dissatisfied

  3. Subject satisfaction [ Time Frame: At 8, 12 and 16 weeks for each subject ]
    Subject satisfaction assessment will be performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very dissatisfied



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  11. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

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.
  11. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area.
  12. Very poor skin quality (i.e., severe laxity).
  13. Abdominal wall diastasis or hernia on physical examination.
  14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
  15. Obesity (BMI > 30).
  16. Pregnant, childbirth within the last 12 months or breastfeeding women.
  17. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.
  18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months).
  19. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
  20. Abdominal fat thickness lower than 2.5 cm after strapping.
  21. Participation in another clinical study within the last 6 months.
  22. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430245


Locations
United States, New Jersey
Skin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Syneron Medical
  Study Documents (Full-Text)

Documents provided by Syneron Medical:

Publications:
Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT03430245     History of Changes
Other Study ID Numbers: DHF24451
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Syneron Medical:
Circumference reduction