UltraShape Power for Abdominal Fat and Circumference Reduction

NCT02748928 | Completed Results

• 1 other identifier: DHF21621
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 8

Brief Summary

Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.

Conditions

Excess Abdominal Fat

Outcome Measures

Primary Outcomes (1)

• Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound

  Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline

  Baseline and 16 weeks (4 weeks treatment + 12 week follow up)

Secondary Outcomes (5)

• Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound

  Baseline and at 4, 8, and 12 weeks (from baseline visit)

• Change in Abdominal Circumference Compared to Baseline

  Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)

• Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome

  8, 12 and 16 weeks (from baseline visit)

• Number of Participants Reporting Satisfaction With Treatment Outcome

  8, 12 and 16 weeks (from baseline visit)

• Pain Scale for Rating Discomfort Associated With Treatment

  Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)

Study Arms (1)

UltraShape Power treatment to abdomen

EXPERIMENTAL

Eligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape Power device according to the study protocol and user manual. The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment, for total expected study duration of 16 weeks

Device: UltraShape Power

Interventions

UltraShape Power DEVICE

Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time

Also known as: UltraShape

UltraShape Power treatment to abdomen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent to participate in the study.
• Female and male subjects, 18 and 60 years of age at the time of enrollment
• Fitzpatrick Skin Type I to VI.
• Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
• Body mass index (BMI): BMI between 22 to 30 (normal to overweight, but not obese).
• 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).
• 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).
• 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 or defibrillator, abdominal aortic aneurism
• Known 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 12 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 or herpes 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 above 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 (8)

Laser Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Prana Medical Aesthetics

Jacksonville Beach, Florida, 32250, United States

Location

Baumann Cosmetic and Research Institute, Inc

Miami, Florida, 33137, United States

Location

DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

A Womans Touch Plastic Surgery

Louisville, Kentucky, 40205, United States

Location

Syneron Candela Institute for Education Clinic

Wayland, Massachusetts, 01778, United States

Location

Union Square Laser Dermatology

New York, New York, 10003, United States

Location

Jewell Plastic Surgery

Eugene, Oregon, 97401, United States

Location

Related Publications (3)

• Ascher B. Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals. Aesthet Surg J. 2010 Mar;30(2):217-24. doi: 10.1177/1090820X09360692.

  PMID: 20442099 BACKGROUND

• Moreno-Moraga J, Valero-Altes T, Riquelme AM, Isarria-Marcosy MI, de la Torre JR. Body contouring by non-invasive transdermal focused ultrasound. Lasers Surg Med. 2007 Apr;39(4):315-23. doi: 10.1002/lsm.20478.

  PMID: 17457840 BACKGROUND

• Chang SL, Huang YL, Lee MC, Chang CH, Lin YF, Cheng CY, Hu S. Long-term follow-up for noninvasive body contouring treatment in Asians. Lasers Med Sci. 2016 Feb;31(2):283-7. doi: 10.1007/s10103-015-1852-0. Epub 2015 Dec 29.

  PMID: 26714982 BACKGROUND

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Syneron Medical

shlomitm@syneron-candela.com

+972-73-2442347

Study Officials

• Ruthie Amir, MD

  Syneron Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: June 8, 2016
• Primary Completion: February 15, 2017
• Study Completion: April 23, 2018
• Last Updated: March 19, 2019
• Results First Posted: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)