NCT03863834

Clinical Evaluation of RFAL of Breast Envelope and NAC Position

Completed NA Results posted Last updated 16 August 2022

What this trial tests

NA trial testing InModeRF in Breast Lift in 12 participants. Completed in 1 April 2020.

Timeline

13 October 2018

Primary endpoint
1 April 2020

1 April 2020

Quick facts

Lead sponsor	InMode MD Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	13 October 2018
Primary completion	1 April 2020
Estimated completion	1 April 2020
Sites	1 location across United States

Drugs / interventions tested

• InModeRF

Conditions studied

• Breast Lift — all drugs for Breast Lift →

Sponsor

InMode MD Ltd.

Who can join

Adults 21 to 60, female only, with Breast Lift. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) Primary · 12 months

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

Group	Value	95% CI
Treatment Arm	20.6	± 1.35

Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data. Primary · 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.

Group	Value	95% CI
Treatment Arm	0

Sponsor's own description

This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.