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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Subjects receive CelluTite treatment followed by Morpheus8 treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CelluTite | Device | CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Katz, MD | 60 E 56th St #2, New York, NY 10022, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juva | New York | New York | 10022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only subjects that finished all visits were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
Adverse event data was collected over a period of 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Subjects receive CelluTite treatment followed by Morpheus8 treatment CelluTite: CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Surgical and medical procedures | Systematic Assessment | Anticipated event of pain post procedure in the treatment area that resolved after approximately a month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Shusterman | InMode | 855.411.2639 | marias@inmodemd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2019 | Dec 4, 2020 | Prot_SAP_000.pdf |
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Subjects will receive the treatment and outcome will be followed
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| 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 | 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 | 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 | 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 | 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 | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | Treatment Day |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cellulite Score Rated According to Cellulite Severity Scale (Dimples) | 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 | Mean | Standard Deviation | score on a scale |
|
| Cellulite Score Rated According to Cellulite Severity Scale (Contour) | 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 | Mean | Standard Deviation | score on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | 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. | Only subjects completed 6 month FU | Posted | Mean | Standard Deviation | score | 6 months |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 month |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 month |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 week |
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| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 week |
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| Primary | 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). | Only subjects completed 3 M FU were analyzed | Posted | Mean | Standard Deviation | score | 3 months |
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| Primary | 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). | Only subjects completed 1 Month FU were analyzed | Posted | Mean | Standard Deviation | score on a scale | 1 month |
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| Primary | 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). | Only subjects completed 1 week FU were analyzed | Posted | Mean | Standard Deviation | score on a scale | 1 week |
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| Primary | 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). | All subjects undergone treatment were analyzed | Posted | Mean | Standard Deviation | score on a scale | Treatment Day |
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| Primary | 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. | Only subjects completed 6 months FU were analyzed | Posted | Mean | Standard Deviation | score | 6 months |
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| Primary | 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). | Only subjects completed 6 M FU were analyzed | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| Primary | 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. | Only subjects completed 6 months FU were analyzed | Posted | Mean | Standard Deviation | score | 3 months |
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| Primary | 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. | Only subjects completed 1 week FU were analyzed | Posted | Mean | Standard Deviation | score | 1 week |
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| Primary | 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. | Only subjects completed treatment were analyzed | Posted | Mean | Standard Deviation | score | Treatment Day |
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| 0 |
| 15 |
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| 15 |
| 4 |
| 15 |
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