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Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Verifiable Subcision (TVS) with the Avéli device, mITT | Experimental | Modified intent to treat population (n=68). The modified intent to treat population was used to evaluate effectiveness. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks |
|
| Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in | Experimental | The roll-in population (n=6) was excluded from the effectiveness analyses. For Investigators that have not previously performed an Avéli procedure, two (2) participants were classified as roll-in participants. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avéli device | Device | Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants | The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None
0 None
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months | The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6. Scale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. G. William Stevens, MD | Marina Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site #3 | Los Angeles | California | 90292 | United States | ||
| Clinical Site #5 |
Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.
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74 was total enrollment:
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| ID | Title | Description |
|---|---|---|
| FG000 | Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | N=68, included in the effectiveness analyses Allocation: non-randomized Intervention Model: Single Group Assignment |
| FG001 | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | N=6, excluded from the effectiveness analyses. The first two participants treated by three Investigators who never used the Avéli device were classified as roll-ins. Allocation: non-randomized Intervention model: Single group assignment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted Verifiable Subcision (TVS) With the Avéli Device | Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. |
| BG001 | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in |
| 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 | The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants | The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None
0 None
| mITT | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
1 year
Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
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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 | Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT | Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Walsh, Senior Manager of Clinical Affairs | Revelle Aesthetics, Inc. | 6509634498 | rwalsh@revelleax.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 | Apr 29, 2021 | Jun 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All participants were treated with the Avéli device.
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| 3 months |
| Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months | The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). Scale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas. | 12 Months |
| The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants | The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None
0 None
| 12 months |
| The Percentage of Patients Satisfied With Their Results at 3 Months | Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses. The lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6. | 3 month |
| The Number of Patients Satisfied With Their Results at 12 Months | Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses. | 12 Months |
| San Diego |
| California |
| 92121 |
| United States |
| Clinical Site #4 | San Francisco | California | 94102 | United States |
| Clinical Site #2 | Coral Gables | Florida | 33146 | United States |
| Clinical Site #6 | Shreveport | Louisiana | 71105 | United States |
| Clinical Site #8 | Chestnut Hill | Massachusetts | 02467 | United States |
| Clinical Site #1 | Minneapolis | Minnesota | 55441 | United States |
| Clinical Site #7 | Southport | Queensland | 4215 | Australia |
| Clinical Site #9 | Toowoomba | Queensland | 4350 | Australia |
Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fitzpatrick Skin Type | Used by site to evaluate the participant's skin type using the following scale: Type 1: light, pale white Type 2: white, fair Type 3: medium white to olive Type 4: olive, moderate brown Type 5: brown, dark brown Type 6: black, very dark, brown to black | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Laxity | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months | The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6. Scale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas. | mITT | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months |
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| Secondary | Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months | The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). Scale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas. | mITT | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months |
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| Secondary | The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants | The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None
0 None
| mITT | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
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| Secondary | The Percentage of Patients Satisfied With Their Results at 3 Months | Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses. The lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 month |
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| Secondary | The Number of Patients Satisfied With Their Results at 12 Months | Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses. | mITT | Posted | Count of Participants | Participants | 12 Months |
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|
| 0 |
| 68 |
| 0 |
| 68 |
| 68 |
| 68 |
| EG001 | Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in | Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite. | 0 | 6 | 0 | 6 | 6 | 6 |
| Tenderness | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Induration | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Incision site bleeding | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Numbness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Edema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Fluid Discharge | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Hemosiderin stain | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Burning sensation | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Tingling | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment | Hyperpigementation of skin |
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| Contact Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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