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This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.
The purpose of this study is to evaluate the safety and efficacy of RFAL for the Breast Envelope and Nipple-Areolar Complex (NAC) Position as measured by Vectra 3D circumferential imaging system (Canfield, NJ)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Subjects receive the RFAL treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InModeRF | Device | InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) | Regular and 3D Vectra photos will be taken at all time points. Additional evaluation of changes in breast shape, including upper pole fullness, breast projection, and bottoming out will be assessed by static measurements (cm) of:
| 12 months |
| Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data. | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatment and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Unger, MD | Maxwell Aesthetics 2020 21st Ave, South, Nashville, TN, 37212, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacob G Unger MD | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only subjects that finished 12 month follow up were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) | Regular and 3D Vectra photos will be taken at all time points. Additional evaluation of changes in breast shape, including upper pole fullness, breast projection, and bottoming out will be assessed by static measurements (cm) of:
| Posted | Mean | Standard Deviation | centimeters | 12 months |
|
|
12 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 the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Shusterman, Clinical Director | Inmode Ltd | 9057070975 | maria.shusterman@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 1, 2018 | Feb 11, 2021 | Prot_SAP_000.pdf |
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Subjects will receive the treatment and outcome will be followed
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Sternal Notch to Left Nipple Distance in centimeters | static measurements in cm of distance from sternal notch to nipple | Mean | Standard Deviation | centimeters |
|
| sternal notch to right nipple distance in cm | Mean | Standard Deviation | centimeters |
|
| right nipple to im crease | Mean | Standard Deviation | centimeters |
|
| left nipple to crease | Mean | Standard Deviation | centimeters |
|
| right base width | Mean | Standard Deviation | centimeters |
|
| left base width | Mean | Standard Deviation | centimeters |
|
| nipple to nipple | Mean | Standard Deviation | centimeters |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data. | Safety will be evaluated by observation, assessment and recording of adverse events, if occur. Evaluations will be done immediately after treatment and at all follow-up visits. Each occurrence will be described in a table presenting data including severity (mild, moderate or severe), causality (relationship to the device or the treatment), treatment and resolution. Data will be summarized and adverse event significance will be considered based on combination of the above listed items. | Posted | Number | number of events | 12 months |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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