CompletedNot Applicable

Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

Canada21 participantsStarted 2012-10

Plain-language summary

The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

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.

✓. Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
✓. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
✓. General good health confirmed by medical history and skin examination of the treated area
✓. Written informed consent to participate in the study
✓. Ability to comply with the requirements of the study
✓. BMI≤ 30

✕. 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 or malignancy
✕. Previous liposuction in the treatment areas
✕. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
✕. 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
✕. Poor skin quality (i.e., 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

Difference in circumference reduction between baseline and follow-up visits

Timeframe: Base line, 2 and 12 weeks post last treatment

NCT IDNCT02154113

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

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.

✓. Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
✓. For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
✓. General good health confirmed by medical history and skin examination of the treated area
✓. Written informed consent to participate in the study
✓. Ability to comply with the requirements of the study
✓. BMI≤ 30

✕. 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 or malignancy
✕. Previous liposuction in the treatment areas
✕. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
✕. 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
✕. Poor skin quality (i.e., 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