VelaShape III & UltraShape Power for Thigh Circumference Reduction

• 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: Syneron Medical
• Information provided by (Responsible Party): Syneron Medical

Tracking Information

• First Submitted Date: January 24, 2018
• First Posted Date: February 12, 2018
• Results First Submitted Date: December 10, 2019
• Results First Posted Date: December 26, 2019
• Last Update Posted Date: January 9, 2020
• Actual Study Start Date: February 19, 2018
• Actual Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: VelaShape III & UltraShape Power for Thigh Circumference Reduction
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Circumference Reduction

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 10, 2019): 16
• Original Estimated Enrollment (submitted: February 9, 2018): 40
• Actual Study Completion Date: July 3, 2019
• Actual Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03430245
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Syneron Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Syneron Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Syneron Medical
• Verification Date: December 2019