UltraShape Power Device for Fat Reduction in Flanks

Not Applicable

Withdrawn

• Conditions: Excess Abdominal Fat
• Interventions: Device: UltraShape Power device

• Registration Number: NCT03502473
• Lead Sponsor: Syneron Medical

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2018-03-07
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Primary Completion: 2019-03-07
• Study Completion: 2019-09-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple passes treatment arm	UltraShape Power device	Second flank will be treated with UltraShape Power device with multiple passes.
One pass/no treatment arm	UltraShape Power device	One random flank will be treated with UltraShape Power device with one pass or remained as a control (no treatment)

Primary Outcome Measures

Name	Time	Method
Treatment Safety as Assessed by Blood Lipid Level	up to 24 weeks	Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values \[%\]
Fat Volume reduction	12 weeks follow-up (12wk FU) versus baseline	MRI measurements for fat thickness in cc (cubic centimeter)

Secondary Outcome Measures

Name	Time	Method
Ultrasound Measurement of Fat Thickness Reduction	4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.	Ultrasound measurements for Fat thickness in mm
Fat Volume reduction	4 weeks, 8 weeks and (optional) 24 weeks versus baseline.	MRI measurements for fat thickness in cc (cubic centimeter)
MRI Measurement of Fat Thickness Reduction	4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.	MRI measurements for Fat thickness in mm

Trial Locations

Locations (1)

The Baruch Padeh Medical Center; 🇮🇱 Tiberias, Israel