Breast LiftNCT03863834
Clinical Evaluation of RFAL of Breast Envelope and NAC Position
A study testing InModeRF in people with Breast Lift, run by InMode MD Ltd. at 1 site in United States.
Trial summary
This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Lift
- What is being tested?
- InModeRF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent agreement signed by the subject.
- Healthy females 21 to 60 years of age.
- Presence of grade I-III Breast Ptosis, mastopexy with history of breast augmentation, correction of asymmetry, mastopexy alone, mastopexy following implant removal and modest breast reduction in combination with or without lipoaspiration.
- Post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- All participants must have a recorded mammogram before the beginning of the study.
Who cannot join
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- History of bleeding coagulopathies or use of anticoagulants in the last 2 weeks.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
Show all 19Show fewer
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- Significant systemic illness or occult systemic illness.
- Illness, infection or skin diseases localized in area of treatment.
- Other therapies or medication which may interfere with treatment.
- Breastfeeding, pregnant, or planning to become pregnant during the study.
- Allergy to lidocaine or other anaesthesia.
- Recent surgery in treatment area within the past 6 months.
- Participation in a study of another device or drug within 3 months prior to enrolment or during this study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the patient to participate in this study.
- As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Safety and Efficacy of Radio-Frequency Assisted Lipolysis (RFAL) of Breast Envelope and Nipple-Areolar Complex (NAC) Position
This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.
Read the detailed description
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)
- Conditions
- Breast Lift
- Being tested
- InModeRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InModeRFDevice
InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Subjects receive the RFAL treatment Receives: Device: InModeRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Sternal Notch to Nipple
- Nipple to Inframammary Fold (IMF)
- Base Width (at point of breast take off from chest wall)
- Nipple to nipple
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start13 Oct 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast LiftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive the treatment and outcome will be followed
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Unger, MD, Principal investigator, Maxwell Aesthetics 2020 21st Ave, South, Nashville, TN, 37212, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863834
- Sponsor's protocol ID
- D0607738
- Status last verified
- Feb 2021
- First submitted
- 27 Feb 2019
- Last updated
- 16 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Efficacy of Radio-Frequency Assisted Lipolysis (RFAL) of Breast Envelope and Nipple-Areolar Complex (NAC) Position
- ClinicalTrials.gov ID
- NCT03863834
- Acronym / sponsor ID
- D0607738
- Conditions
- Breast Lift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Posted 16 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single center clinical study is intended to determine the safety and efficacy of using Radiofrequency (RF) energy for minimally invasive breast lift procedure.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive the treatment and outcome will be followed
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: InModeRFSubjects receive the RFAL treatment |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent agreement signed by the subject.
- Healthy females 21 to 60 years of age.
- Presence of grade I-III Breast Ptosis, mastopexy with history of breast augmentation, correction of asymmetry, mastopexy alone, mastopexy following implant removal and modest breast reduction in combination with or without lipoaspiration.
- Post-menopausal or surgically sterilized or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
Key exclusion criteria (19 listed)
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance.
- Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- History of bleeding coagulopathies or use of anticoagulants in the last 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InModeRFInModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology | Device | Treatment arm |
Primary outcome
Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple)
Time frame: 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
Number of Adverse Events Will be Assessed Based on Frequency, Severity and Causality Data.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Unger, MD principal investigator
Maxwell Aesthetics 2020 21st Ave, South, Nashville, TN, 37212, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InModeRF in people with Breast Lift, run by InMode MD Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of Distance (cm) Between Breast Area Reference Points (Nipple to Nipple) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.