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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Evolve System | Device | EMS and RF Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months following last treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avance Plastic Surgery Institute | Reno | Nevada | 89511 | United States | ||
| BodySculpt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 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. Treatment with Evolve System: EMS and RF Treatment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age will be collected at baseline as a continuous variable, recorded in years. |
| 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 | 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. | Posted | Median | Full Range | centimeters (cm) | Baseline to 6 months following last treatment session |
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From first treatment session through 6 months after the last treatment session.
Adverse events were assessed throughout the study period from the first treatment session through the 6-month follow-up visit. All adverse events were collected via subject questioning and clinical evaluation at each visit.
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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 | 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. Treatment with Evolve System: EMS and RF Treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Shusterman | Inmode | 9492396522 | 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 | Sep 19, 2019 | Jan 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. | 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. | 6 months |
| New York |
| New York |
| 10019 |
| United States |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Sex will be recorded at baseline as a categorical variable. Categories: Male, Female. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type was assessed at baseline using the standard Fitzpatrick classification system based on skin response to sun exposure. Type I: Always burns, never tans Type II: Usually burns, tans minimally Type III: Sometimes mild burn, tans uniformly Type IV: Rarely burns, tans well Type V: Very rarely burns, tans very easily Type VI: Never burns, deeply pigmented Fitzpatrick Skin Type is a descriptive classification and does not represent a better or worse outcome. | Count of Participants | Participants |
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| Secondary | 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 | Posted | Mean | Standard Deviation | score (0-4 Likert scale) | 6 month |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score (0-4 Likert scale) | 6 Months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 17 |
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| 17 |
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