This study was designed to demonstrate safety and efficacy of the XP1000 RF for non-invasive temporary reduction of waist circumference by disruption of adipocyte cells.
This study is a prospective, double-blinded, randomized, two-arm sham-controlled study of circumferential waist reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day and 90-day Follow Up in achieving waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of sham group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Treatment of adipose tissue within the fat layer with XP1000 RF.
Treatment of adipose tissue within the fat layer with XP1000 RF.
Waist Circumferential reduction
The primary efficacy outcome measure is set to be a minimum of 80% of subjects in the XP1000 RF group at 30-day follow up evaluation to show waist circumference reduction of ≥3 cm across the waist line relative to the base line assessment and their mean waist circumferential reduction is ≥1 cm than the average circumferential reduction of Sham group.
Time frame: 30 days follow follow up after 4 once-a-week treatments
Adverse Events
Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits
Time frame: 1 month follow up
Adverse Events
Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits
Time frame: 3 months follow up
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