Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area
The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction after Evoke treatment for face and submental area Prospective, open label clinical study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Treatment areas include face, under chin (submental) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoke radiofrequency device | Device | Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Change in Skin Appearance | Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Investigator Assessment of the Skin Appearance | Evaluate Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 6 months follow up visits. 0-no change, 1- mild improvement, 2- moderate improvement, 3- marked improvement, 4- significantly marked improvement | month 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rodney Rohrich, MD | Dallas Plastic Surgery Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Medical Group | Sacramento | California | 95816 | United States | ||
| AboutSkin dermatology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments, |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects aged 35-75, healthy adults with visible signs of aging, seeking skin laxity treatments.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments, |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluate Change in Skin Appearance | Evaluate change in skin appearance comparing pre and 6 months post last treatment photographs (as assessed by blinded investigators) | 2 of 3 blind evaluators would agree on skin appearance based on photographs for 70% of patients | Posted | Number | percentage of participants | Month 6 |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Treatment areas include face, under chin (submental) Evoke radiofrequency device: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments, |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Shusterman | InMode | 9057076787 | Maria.Shusterman@inmodemd.com |
Not provided
| 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 | Oct 29, 2020 | Mar 30, 2023 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Evaluate Subject Assessment of Improvement and Satisfaction | Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points Likert scale at 6 months follow up visits, Improvement: 0-no change, 1- mild improvement, 2- moderate improvement, 3-marked improvement, 4- significantly marked improvement. | month 6 |
| Patient Satisfaction With the Procedure | Finally, patients assessed their satisfaction with the procedure at 6 months post-treatment. Patients utilized a scale anchored by -2 (very disappointed) and 2 (very satisfied). | month 6 |
| Greenwood Village |
| Colorado |
| 80111 |
| United States |
| Lupo Center for Aesthetic and General Dermatology | New Orleans | Louisiana | 70124 | United States |
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | United States |
| Refresh dermatology | Houston | Texas | 77081 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Evaluate Investigator Assessment of the Skin Appearance | Evaluate Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 6 months follow up visits. 0-no change, 1- mild improvement, 2- moderate improvement, 3- marked improvement, 4- significantly marked improvement | Investigator assessment of the skin appearance improvement comparing pre and post-treatment using 0 - 4 -points Likert scale at 6 months follow-up visits. | Posted | Mean | Full Range | score on a scale | month 6 |
|
|
|
| Secondary | Evaluate Subject Assessment of Improvement and Satisfaction | Evaluate Subject assessment of improvement and satisfaction using 0 - 4 -points Likert scale at 6 months follow up visits, Improvement: 0-no change, 1- mild improvement, 2- moderate improvement, 3-marked improvement, 4- significantly marked improvement. | Patients assessed the level of their skin appearance improvement at 6 months post-treatment. Patients utilized a scale anchored by 0 (no difference) and 4 (significantly marked improvement) | Posted | Mean | Full Range | score on a scale | month 6 |
|
|
|
| Secondary | Patient Satisfaction With the Procedure | Finally, patients assessed their satisfaction with the procedure at 6 months post-treatment. Patients utilized a scale anchored by -2 (very disappointed) and 2 (very satisfied). | Posted | Mean | Full Range | score on a scale | month 6 |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 5 |
| 85 |
| hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| mild tenderness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |