This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.
The study will evaluate the safety and efficacy of cellulite treatment using two hand pieces: * The CelluTite - based on a minimally invasive, temperature-controlled Radiofrequency-assisted lipolysis (RFAL) technology. RF energy is applied using a handpiece with 2 electrodes: internal active electrode with spatula-shaped tip and external electrode. * The Morpheus8 - designed to deliver RF energy to the skin surface in a fractional manner via an array of 24-electrode pins.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Juva
New York, New York, United States
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Time frame: 6 months
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Time frame: 6 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 6 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Time frame: 6 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 1month follow-up visits will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
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Time frame: 1 month
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 3 months follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Time frame: 3 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos 1 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Time frame: 1 month
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos 3 month follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Time frame: 3 months
Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)
Photos 1 week follow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating cellulite dimples, in which a dimple is an isolated circular or oval-shaped depression on the surface of the skin. (A) Score 0 (no dimples); (B) score 1 (1 dimple); (C) score 2 (2 dimples); (D) score 3 (3 dimples); (E) score 4 (4 or more dimples). Higher values represent a worse outcome
Time frame: 1 week
Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)
Photos from 1 week ollow-up visit will be evaluated. Evaluation goals are rating the degree of cellulite according to the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS). Scale for evaluating contour irregularities. The irregularities become more severe as more concavity and convexity occur in the linear undulations. Score 0-none-no depressions ; score 1 superficial: generalized, small depressions with no protuberances; score 2 mild: pattern of mild linear undulations; score 3 moderate: pattern of moderate linear undulations with alternating areas of protuberances and depressions; score 4 severe: severe generalized linear undulations with alternating areas of protuberances and depressions. higher values represent a worse outcome
Time frame: 1 week
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Time frame: 3 months
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Time frame: 1 month
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Time frame: 1 week
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Time frame: Treatment Day
Assessment of Adverse Events Occurrence Based on Severity
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done based on severity (none 0, mild 1, moderate 2 or severe 3).
Time frame: 6 Months
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Time frame: 3 months
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Time frame: 1 week
Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)
Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Casualty: relationship to the device or the treatment 0 - no adverse event, 1 - not related and 2 - related to device). Higher values represent a worse outcome.
Time frame: Treatment Day