Non-invasive Circumference ReductionNCT04124419
Safety and Efficacy of Combined EMS and RF Treatments
A study testing Treatment with Evolve System in people with Non-invasive Circumference Reduction, run by InMode MD Ltd. at 2 sites in United States.
Trial summary
The objective of this trial is to evaluate the safety and efficacy of the Evolve device utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction and skin tightening Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-invasive Circumference Reduction
- What is being tested?
- Treatment with Evolve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jul 2019to 19 May 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Signed informed consent to participate in the study.
- Female and male subjects,18 - 65 years of age at the time of enrolment
- BMI≤ 30
- If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
- In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
- General good health confirmed by medical history and skin examination of the treated area.
- Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
- The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Who cannot join
- - Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
- Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
- Intra-dermal or superficial sub-dermal areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy and nursing.
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- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, autoimmune disorders or use of immunosuppressive medications.
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- 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.
- History of bleeding coagulopathies, or use of anticoagulants in the last 10 days.
- Any surgical procedure in the treatment area within the last 6 months or before complete healing.
- Having received treatment with light, laser, RF, or other devices in the treated area within 3 months, or before complete healing.
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
BodySculpt
New York, New York, 10019
Avance Plastic Surgery Institute
Reno, Nevada, 89511
About this study
Official title: Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF Treatments for Non-Invasive Circumference Reduction and Skin Tightening
The objective of this trial is to evaluate the safety and efficacy of the Evolve device utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction and skin tightening
- Conditions
- Non-invasive Circumference Reduction
- Being tested
- Treatment with Evolve System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Evolve SystemDevice
EMS and RF Treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol. Receives: Device: Treatment with Evolve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Circumference Reduction
Change in circumference measured in centimeters from baseline to 6 months following the last treatment session. Circumference was measured using a standard measuring tape. Negative values indicate a reduction in circumference.
Measured: Baseline to 6 months following last treatment session
Secondary outcomes (3)
Change in Abdomen Area Appearance Assessed by Investigator
- Investigator assessment of the skin appearance comparing pre and post treatment using 0 - 4 -points Likert scale at follow up visits: 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference Higher score = better improvement
Measured: 6 month
Subject Improvement Assessment
Improvement assessment will be performed independently by the subject himself using 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows:
4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference.
Measured: 6 Months
Subject Satisfaction Assessment
Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows:
+2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed. Higher scores indicate greater satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start19 Jul 2019
- Primary completion19 May 2021
- Study completion19 May 2021
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 Non-invasive Circumference ReductionStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124419
- Sponsor's protocol ID
- DO608715A
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2019
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF Treatments for Non-Invasive Circumference Reduction and Skin Tightening
- ClinicalTrials.gov ID
- NCT04124419
- Acronym / sponsor ID
- DO608715A
- Conditions
- Non-invasive Circumference Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to evaluate the safety and efficacy of the Evolve device utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction and skin tightening
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Treatment with Evolve SystemEligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - Signed informed consent to participate in the study.
- Female and male subjects,18 - 65 years of age at the time of enrolment
- BMI≤ 30
- If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrolment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
- In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
Key exclusion criteria (16 listed)
- - Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
- Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
- Intra-dermal or superficial sub-dermal areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
- Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
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 |
|---|---|---|
| Treatment with Evolve SystemEMS and RF Treatment | Device | Treatment Arm |
Primary outcome
Change in Circumference Reduction
Time frame: Baseline to 6 months following last treatment session
Change in circumference measured in centimeters from baseline to 6 months following the last treatment session. Circumference was measured using a standard measuring tape. Negative values indicate a reduction in circumference.
3 secondary outcomes
Change in Abdomen Area Appearance Assessed by Investigator
Time frame: 6 month
Subject Improvement Assessment
Time frame: 6 Months
Subject Satisfaction Assessment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Evolve System in people with Non-invasive Circumference Reduction, run by InMode MD Ltd. at 2 sites 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 8 inclusion and 16 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 27 Feb 2026). 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?
Change in Circumference Reduction (time frame: Baseline to 6 months following last treatment session). 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 27 Feb 2026.