UltraShape Power Device for Fat Reduction in Flanks

Excess Abdominal Fat Clinical Trial

Official title:

Clinical Assessment to Evaluate UltraShape Power Device Performance for Flanks Fat Reduction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03502473
• Other study ID #: DHF24961
• Status: Withdrawn
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: September 7, 2019

Study information

• Verified date: January 2020
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.

Description:

Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device according to the study protocol.

One random flank will be treated with one pass or remained as a control (no treatment) while the second flank will be treated with multiple passes.

Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks following end of treatment/s.

Each subject will be enrolled for total expected study duration of up to 28 weeks.

After last follow up visit, subjects who wish will receive compensation treatments (up to 3) on the flank who received regular treatment (single pass) or remained as a control (no treatment).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent to participate in the study.

2. Female and male subjects, 18 and 65 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: 19 = BMI = 30 (normal to overweight, but not obese).

6. If female, not pregnant, lactating and 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 pregnancy inquiry as reviewed before each treatment and each follow up visit for women with 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. Current 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 3 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 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 > 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., ± 3% weight change in the prior six months)

17. Inability to comply with fat measurement procedures (e.g., inability to hold breath for few seconds).

18. Fat thickness lower than 1.5 cm before strapping at the treated area.

19. Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).

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

Related Conditions & MeSH terms

• Excess Abdominal Fat

Intervention

Device:
• UltraShape Power device
UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts: The Main console Transducer

Locations

Country	Name	City	State
Israel	The Baruch Padeh Medical Center	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Volume reduction	MRI measurements for fat thickness in cc (cubic centimeter)	12 weeks follow-up (12wk FU) versus baseline
Primary	Treatment Safety as Assessed by Blood Lipid Level	Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values [%]	up to 24 weeks
Secondary	MRI Measurement of Fat Thickness Reduction	MRI measurements for Fat thickness in mm	4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Secondary	Ultrasound Measurement of Fat Thickness Reduction	Ultrasound measurements for Fat thickness in mm	4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Secondary	Fat Volume reduction	MRI measurements for fat thickness in cc (cubic centimeter)	4 weeks, 8 weeks and (optional) 24 weeks versus baseline.