This study was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.
This study is a prospective, single-arm, open label study of thighs circumference 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 in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Treatment of adipose tissue within the fat layer with XP1100RF device.
Thighs Circumference Reduction from Baseline at 30 days Follow Up
The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment.
Time frame: 30 days 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: 30 days 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
Subject satisfaction assessed by questionnaires
Subject satisfaction as assessed by questionnaires administered at 30 days follow up.
Time frame: 30 days Follow Up
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