UltraShape Power for Abdominal Fat and Circumference Reduction

NCT ID: NCT02748928

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-08
• Study Completion Date: 2018-04-23

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.

Conditions

Excess Abdominal Fat

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UltraShape Power treatment to abdomen

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

Group Type: EXPERIMENTAL

UltraShape Power

Intervention Type: 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

Interventions

UltraShape Power

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

Intervention Type: DEVICE

Other Intervention Names

UltraShape

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruthie Amir, MD

Role: STUDY_DIRECTOR

Syneron Medical

Locations

Laser Skin Surgery Center of Northern California

Sacramento, California, United States

Prana Medical Aesthetics

Jacksonville Beach, Florida, United States

Baumann Cosmetic and Research Institute, Inc

Miami, Florida, United States

DuPage Medical Group

Naperville, Illinois, United States

A Womans Touch Plastic Surgery

Louisville, Kentucky, United States

Syneron Candela Institute for Education Clinic

Wayland, Massachusetts, United States

Union Square Laser Dermatology

New York, New York, United States

Jewell Plastic Surgery

Eugene, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20442099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17457840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26714982 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DHF21621

Identifier Type: -

Identifier Source: org_study_id