Clinical trial NCT02748928: UltraShape Power for Abdominal Fat and Circumference Reduction
Official title: Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excess Abdominal Fat
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Third Treatment).

Each subject will be enrolled for total expected study duration of 16 weeks. Subject's abdominal fat thickness and circumference will be measured at the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.

Eligibility criteria: Inclusion Criteria:

A subject is eligible to participate in the study if he/she meets all the following 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 enrollment
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. Body mass index (BMI): BMI between 22 to 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:

A subject is not eligible for participation in this study if he or she meets any of the following exclusion criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker or 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 above 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 percent 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. Fat thickness lower than 2.5 cm after 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 trials)
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.

Primary outcomes:
measure: Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
timeFrame: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)
Secondary outcomes:
measure: Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
timeFrame: Baseline and at 4, 8, and 12 weeks (from baseline visit)
measure: Change in Abdominal Circumference Compared to Baseline
timeFrame: Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)
measure: Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
timeFrame: 8, 12 and 16 weeks (from baseline visit)
measure: Number of Participants Reporting Satisfaction With Treatment Outcome
timeFrame: 8, 12 and 16 weeks (from baseline visit)
measure: Pain Scale for Rating Discomfort Associated With Treatment
timeFrame: Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser Skin Surgery Center of Northern California
state: California
city: Jacksonville Beach
country: United States
facility: Prana Medical Aesthetics
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute, Inc
state: Florida
city: Naperville
country: United States
facility: DuPage Medical Group
state: Illinois
city: Louisville
country: United States
facility: A Womans Touch Plastic Surgery
state: Kentucky
city: Wayland
country: United States
facility: Syneron Candela Institute for Education Clinic
state: Massachusetts
city: New York
country: United States
facility: Union Square Laser Dermatology
state: New York
city: Eugene
country: United States
facility: Jewell Plastic Surgery
state: Oregon
Study officials:
affiliation: Syneron Medical
name: Ruthie Amir, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.