UltraShape Device for Thigh Fat and Circumference Reduction vs. Control

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2016
• Main ID: NCT02488083
• Date of registration: 26/05/2015
• Prospective Registration: Yes
• Primary sponsor: Syneron Medical
• Public title: UltraShape Device for Thigh Fat and Circumference Reduction vs. Control
• Scientific title: Clinical Study to Evaluate the Performance of the UltraShape Device for Thighs Fat and Circumference Reduction vs. Control
• Date of first enrolment: June 2015
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02488083
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Robert Weiss, MD
• Affiliation: Maryland Laser, Skin and Vein Institute

• Name: Robert Weiss, MD

Key inclusion & exclusion 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 enrolment

3. Fitzpatrick Skin Type I to VI.

4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated
caliper).

5. BMI interval: BMI in range of 22- 30 (normal to overweight, but not obese).

6. If female, not pregnant or lactating, 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 follow-up visit for women with child-bearing potential (e.g. not menopause).

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. 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

10. 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

11. Very poor skin quality (i.e., severe laxity)

12. Abdominal wall diastasis or hernia on physical examination

13. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood
count within the last 3 months

14. Obesity (BMI bigger than 30)

15. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic
condition which, in the opinion of the investigator, could interfere with the conduct
of the study

16. Unstable weight within the last 6 months (i.e tolerance of 3% weight change in the
prior six months)

17. Inability to comply with circumference measurement procedure (e.g., inability to hold
breath for the required duration).

18. Participation in another clinical study within the last 6 months.

19. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Unwanted Thigh Fat

Intervention(s)

Device: Ultrashape

Primary Outcome(s)

evaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction [Time Frame: 8 weeks up to 20 weeks]

Secondary Outcome(s)

Investigator satisfaction by questionnaire [Time Frame: 8 weeks, 12 weeks, 20 weeks]

safety issues assessed by The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response) [Time Frame: day 0 up to 20 weeks]

thigh circumference reduction [Time Frame: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment,]

thigh fat thickness reduction by caliper [Time Frame: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks]

thigh fat thickness reduction by ultrasound [Time Frame: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks]

Subject satisfaction by questionnaire [Time Frame: 8 weeks, 12 weeks, 20 weeks]

Comfort level by NSR scale [Time Frame: day 0, 2 weeks, 4 weeks]

Secondary ID(s)

DHF17991

Source(s) of Monetary Support

Please refer to primary and secondary sponsors