Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat Reduction

Last updated: February 15, 2018
Sponsor: Syneron Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02700152
DHF18531
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction.

Study subjects will undergo UltraShape treatments on the abdominal area

Eligibility Criteria

Inclusion

Inclusion Criteria: A subject is eligible to participate in the study if he/she meets all the followinginclusion 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. BMI interval: BMI between 22 to 30 (normal to overweight, but not obese).

  6. If female, not pregnant or lactating, must be either post-menopausal, surgicallysterilized, or using a medically acceptable form of birth control at least 3 monthsprior to enrollment (i.e. oral contraceptives, contraceptive implant, barrier methodswith spermicide or abstinence).

  7. In addition, negative urine pregnancy test as tested before each treatment and at thelast 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 treatedarea.

  9. Willing to follow the treatment and follow-up schedule and post-treatment careinstructions.

  10. Willingness to refrain from a change in diet/ exercise/medication regimen for theentire 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

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

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestiveheart failure, pacemaker or defibrillator, abdominal aortic aneurism

  2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positivestatus, blood coagulopathy or excessive bleeding, autoimmune or connective tissuedisease

  3. Having or undergoing any form of treatment for active cancer, or having a history ofskin cancer or any other cancer in the areas to be treated, including presence ofmalignant or pre‐malignant pigmented lesions

  4. Having any active electrical implant anywhere in the body, such as a pacemaker or aninternal defibrillator

  5. Having a permanent implant in the treated area, such as metal plates or an injectedchemical substance such as silicone

  6. Having undergone any other surgery in the treated areas within 12 months of treatmentor 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 poorwound healing

  9. Suffering from significant skin conditions in the treated areas or inflammatory skinconditions, including, but not limited to, open lacerations or abrasions and activecold sores or herpes sores prior to treatment (duration of resolution as per theInvestigator'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 treatmentarea

  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 countwithin the last 3 months

  14. Obesity (BMI above 30)

  15. Childbirth within the last 12 months or breastfeeding women. Any acute or chroniccondition which, in the opinion of the investigator, could interfere with the conductof the study

  16. Unstable weight within the last 6 months (i.e., ± 3 percent weight change in the priorsix months)

  17. Inability to comply with circumference measurement procedure (e.g., inability to holdbreath 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 thelast 6 months (or 30 days in case different anatomical areas were treated in previoustrials).

  20. As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study

Study Design

Total Participants: 60
Study Start date:
January 01, 2016
Estimated Completion Date:
November 30, 2020

Study Description

This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive abdominal fat reduction.

Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumference will be measured and three successive UltraShape treatments, two weeks interval, will be performed.

The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference will be measured in 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.

Connect with a study center

  • Skin Care Physicians

    Chestnut Hill, Massachusetts 02467
    United States

    Completed

  • Zel Skin & Laser Specialists

    Edina, Minnesota 55402
    United States

    Active - Recruiting

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