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VelaShape III & UltraShape Power for Thigh Circumference Reduction

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ClinicalTrials.gov Identifier: NCT03430245
Recruitment Status : Completed
First Posted : February 12, 2018
Results First Posted : December 26, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Syneron Medical

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE February 12, 2018
Results First Submitted Date  ICMJE December 10, 2019
Results First Posted Date  ICMJE December 26, 2019
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE February 19, 2018
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
Circumference Change 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 change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits [ Time Frame: At 2, 4, 8 and 12 weeks after baseline ]
    The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline. The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively). Negative change represent reduction in thigh circumference.
  • Investigator Satisfaction [ Time Frame: At 4, 8 and 12 weeks follow-up visits ]
    Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)
  • Subject Satisfaction [ Time Frame: At 4, 8 and 12 week follow-up visits ]
    Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VelaShape III & UltraShape Power for Thigh Circumference Reduction
Official Title  ICMJE Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Circumference Reduction
Intervention  ICMJE
  • Device: VelaShape III
    The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
  • Device: UltraShape Power
    The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
Study Arms  ICMJE Experimental: VelaShape III & UltraShape Power
VelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment.
Interventions:
  • Device: VelaShape III
  • Device: UltraShape Power
Publications * Coleman WP 3rd, Coleman W 4th, Weiss RA, Kenkel JM, Ad-El DD, Amir R. A Multicenter Controlled Study to Evaluate Multiple Treatments With Nonthermal Focused Ultrasound for Noninvasive Fat Reduction. Dermatol Surg. 2017 Jan;43(1):50-57. doi: 10.1097/DSS.0000000000000918.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
40
Actual Study Completion Date  ICMJE July 3, 2019
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430245
Other Study ID Numbers  ICMJE DHF24451
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Syneron Medical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Syneron Medical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Syneron Medical
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP