UltraShape Power Device for Fat Reduction in Flanks

NCT03502473 | Withdrawn

• 1 other identifier: DHF24961
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Excess Abdominal Fat

Keywords

fat flanks

Outcome Measures

Primary Outcomes (2)

• Fat Volume reduction

  MRI measurements for fat thickness in cc (cubic centimeter)

  12 weeks follow-up (12wk FU) versus baseline

• 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 Outcomes (3)

• MRI Measurement of Fat Thickness Reduction

  4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.

• Ultrasound Measurement of Fat Thickness Reduction

  4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.

• Fat Volume reduction

  4 weeks, 8 weeks and (optional) 24 weeks versus baseline.

Study Arms (2)

One pass/no treatment arm

EXPERIMENTAL

One random flank will be treated with UltraShape Power device with one pass or remained as a control (no treatment)

Device: UltraShape Power device

Multiple passes treatment arm

EXPERIMENTAL

Second flank will be treated with UltraShape Power device with multiple passes.

Device: UltraShape Power device

Interventions

UltraShape Power device 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

Multiple passes treatment arm; One pass/no treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study.
• Female and male subjects, 18 and 65 years of age at the time of enrolment
• Fitzpatrick Skin Type I to VI.
• Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
• BMI interval: 19 ≤ BMI ≤ 30 (normal to overweight, but not obese).
• 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).
• In addition, negative pregnancy inquiry as reviewed before each treatment and each follow up visit for women with bearing potential (e.g. not menopause).
• General good health confirmed by medical history and skin examination of the treated area.
• Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
• Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
• Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

You may not qualify if:

• History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
• Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
• 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
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
• Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
• Having undergone any other surgery in the treated areas within 3 months of treatment or during the study, including liposuction
• Previous body contouring procedures in the treatment area within 12 months
• History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
• 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
• 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
• Very poor skin quality (i.e., severe laxity)
• Abdominal wall diastasis or hernia on physical examination
• Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
• Obesity (BMI \> 30)
• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

The Baruch Padeh Medical Center

Tiberias, Israel

Location

Study Officials

• Michael Jerdev, MD

  The Baruch Padeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Flanks will be randomized in accordance with randomization list. One flank will receive a single treatment pass or no treatment. The other side will receive multiple passes (up to 5 passes) during the same treatment session.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 18, 2018
• Study Start: March 7, 2018
• Primary Completion: March 7, 2019
• Study Completion: September 7, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)