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At least 90 female and male subjects, from 6 investigational sites, aged 18-70 seeking non-invasive lipolysis and circumference reduction of abdomen will be enrolled. Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).
The goal of this prospective study is to evaluate Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen.
The main questions are :
Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | 3 bi-weekly treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trim II | Device | Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Trim II hands-free applicator composed of 4 units applied to the abdominal area, using a single-use belt. Each treatment duration will be 45-60 minutes. Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline. | Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months follow-up visit comparing to baseline. Success criteria: Statistically significant reduction in abdominal circumference tape measurements at the 3 months follow-up visit compared to baseline | 3 months |
| Safety of the Trim II Treatment for Lipolysis and Abdominal Circumference Reduction. | Number of participants with incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) will be followed throughout the whole study. Observation, assessment, and recording of potential reactions by the investigator. Evaluations will be done immediately after each treatment and at the follow-up visits. The frequency, severity, and causality of reactions will be recorded. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Baseline and 3 Month Abdomen Photographs Correctly Identified by Two Blind Evaluators | Success criteria: Correct identification of baseline and 3-month follow-up visit photographs of the abdomen (treatment) area in at least 70% of treated subjects by two blinded evaluators. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H/K/B Cosmetic Surgery | Huntersville | North Carolina | 28078 | United States | ||
| Bucky Body Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36533797 | Derived | Labadie JG, Chilukuri S, Cohen J, Kilmer S, Lupo M, Rohrich R, Dover JS. Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance. Dermatol Surg. 2023 Jan 1;49(1):54-59. doi: 10.1097/DSS.0000000000003666. Epub 2022 Dec 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belts according to the study protocol. Each treatment duration will be 45-60 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | dropouts |
| 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 | Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline. | Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months follow-up visit comparing to baseline. Success criteria: Statistically significant reduction in abdominal circumference tape measurements at the 3 months follow-up visit compared to baseline | treatment arm | Posted | Mean | Standard Deviation | CM | 3 months |
|
3 months
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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 | 3 bi-weekly treatments Trim II: Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Each treatment duration will be 45-60 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Shusterman | InMode | 9057076787 | 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 | Jun 3, 2022 | Mar 4, 2024 | Prot_SAP_001.pdf |
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|
| Change in Abdominal Fat Thickness Measured by Ultrasound Imaging (USI) at the 3 Months Follow-up Visit Comparing to Baseline. |
Success criteria: statistically significant change in fat thickness of the abdomen (treatment) area measurements at the 3 months follow-up visit compared to baseline. |
| 3 months |
| Subject's Satisfaction With Study Treatment at 3 Months Follow-up Visit. | Subject's satisfaction with the therapy results was evaluated through the Subject Satisfaction Questionnaire (5-point scale). The higher the score the better the outcome. 2-Very satisfied, 1-satisfied, 0-indifferent, -1 disappointed, -2- very disappointed | 3 months |
| Treatment Comfort During the Study Treatment. | Average of comfort post treatment evaluated using the Therapy Comfort Questionnaire. Scored from-2 to +2. The higher the score the better the outcome. Average value is calculated | Immediately post each treatment once in 2 weeks for 6 weeks |
| Philadelphia |
| Pennsylvania |
| 19103 |
| United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | United States |
| Refresh Dermatology | Houston | Texas | 77081 | United States |
| Standard Deviation |
| years |
|
| Sex: Female, Male | dropouts | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | dropouts | Number | participants |
|
| Skin type | The Fitzpatrick scale (also Fitzpatrick skin typing test; or Fitzpatrick phototyping scale) is a numerical classification schema for human skin color. Skin color classified to I, II, III, IV or V skin type. Skin type I is the lightest and V is the darkest. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | units of kg/m2 |
|
| Subjects Height | Mean | Standard Deviation | inch |
|
| Subjects Weight | Mean | Standard Deviation | pounds |
|
| Circumference Measurements | Patients had complete baseline and 3-month follow-up data for tape measurement of circumference. There were 3 measurement points for this evaluation: widest circumference, 2 inches above umbilicus, and 2 inches below the umbilicus calculated as average. | Mean | Standard Deviation | cm |
|
| Caliper Measurements | Patients had complete caliper measurements of fat thickness data for baseline and 3-month follow-up timepoints. Caliper measurements were performed on both sides of the belly button and the two measurements are assessed as averaged together | Mean | Standard Deviation | mm |
|
| Ultrasound measurements of fat thickness | Two ultrasound measurements were performed at two time points (baseline and 3 months post-treatment) to measure abdominal subcutaneous fat in the area of the two measurement points. | Mean | Standard Deviation | mm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Safety of the Trim II Treatment for Lipolysis and Abdominal Circumference Reduction. | Number of participants with incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) will be followed throughout the whole study. Observation, assessment, and recording of potential reactions by the investigator. Evaluations will be done immediately after each treatment and at the follow-up visits. The frequency, severity, and causality of reactions will be recorded. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Percentage of Participants With Baseline and 3 Month Abdomen Photographs Correctly Identified by Two Blind Evaluators | Success criteria: Correct identification of baseline and 3-month follow-up visit photographs of the abdomen (treatment) area in at least 70% of treated subjects by two blinded evaluators. | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | Change in Abdominal Fat Thickness Measured by Ultrasound Imaging (USI) at the 3 Months Follow-up Visit Comparing to Baseline. | Success criteria: statistically significant change in fat thickness of the abdomen (treatment) area measurements at the 3 months follow-up visit compared to baseline. | Posted | Mean | Standard Deviation | mm | 3 months |
|
|
|
| Secondary | Subject's Satisfaction With Study Treatment at 3 Months Follow-up Visit. | Subject's satisfaction with the therapy results was evaluated through the Subject Satisfaction Questionnaire (5-point scale). The higher the score the better the outcome. 2-Very satisfied, 1-satisfied, 0-indifferent, -1 disappointed, -2- very disappointed | Posted | Mean | Full Range | score on a scale | 3 months |
|
|
|
| Secondary | Treatment Comfort During the Study Treatment. | Average of comfort post treatment evaluated using the Therapy Comfort Questionnaire. Scored from-2 to +2. The higher the score the better the outcome. Average value is calculated | Posted | Mean | Full Range | score on a scale | Immediately post each treatment once in 2 weeks for 6 weeks |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 2 |
| 75 |
| blisters | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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