WithdrawnNot Applicable

UltraShape Power Device for Fat Reduction in Flanks

Stopped: Sponsor decision was made not to initiate and to focus on other initiatives

Israel0Started 2018-03-07

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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

Fat Volume reduction

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

Treatment Safety as Assessed by Blood Lipid Level

Timeframe: up to 24 weeks

NCT IDNCT03502473

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-07

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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