Trial Outcomes & Findings for Clinical Evaluation of RFAL of Breast Envelope and NAC Position (NCT NCT03863834)

Last Updated: 2022-08-16

Results Overview

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: * Sternal Notch to Nipple * Nipple to Inframammary Fold (IMF) * Base Width (at point of breast take off from chest wall) * Nipple to nipple

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

12 months

Results posted on

2022-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Overall Study STARTED	12
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Overall Study Lost to Follow-up	3

Baseline Characteristics

Clinical Evaluation of RFAL of Breast Envelope and NAC Position

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=9 Participants Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Age, Continuous	38.6 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Sternal Notch to Left Nipple Distance in centimeters	24.56 centimeters STANDARD_DEVIATION 1.88 • n=5 Participants
sternal notch to right nipple distance in cm	25.25 centimeters STANDARD_DEVIATION 2.20 • n=5 Participants
right nipple to im crease	11.44 centimeters STANDARD_DEVIATION 3.18 • n=5 Participants
left nipple to crease	12.44 centimeters STANDARD_DEVIATION 3 • n=5 Participants
right base width	12.93 centimeters STANDARD_DEVIATION 1.76 • n=5 Participants
left base width	13.29 centimeters STANDARD_DEVIATION 2.14 • n=5 Participants
nipple to nipple	21.63 centimeters STANDARD_DEVIATION 1.71 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple)	20.6 centimeters Standard Deviation 1.35

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=9 Participants Subjects receive the RFAL treatment InModeRF: InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data.	0 number of events

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Shusterman, Clinical Director

Inmode Ltd

Phone: 9057070975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place