Adipose Tissue Atrophy
Conditions
Keywords
fat, abdomen fat, flank fat, body contouring
Brief summary
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
Detailed description
Open-label, baseline-controlled, multi-center study evaluating a 1060 nm diode laser, pulsed electromagnetic fields, and vacuum-assisted radio frequency for non-invasive fat reduction of the abdomen and flanks. The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive 3 study treatments of the diode laser and 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency. Subjects will be followed at twelve weeks post-final diode treatment. The twelve-week post-treatment outcome will be compared to the baseline.
Interventions
DEVICEVenus Bliss
The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Up to 200 subjects will be enrolled in the study to receive 3 Diode and 3 RF treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\. Able to read, understand and voluntarily provide written informed consent. 2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks. 3\. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study. 5\. Able and willing to comply with the treatment/follow-up schedule and requirements. 6\. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
Exclusion criteria
* 1\. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months. 2\. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months. 3\. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study. 4\. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding. 5\. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment. 6\. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions. 7\. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate). 8\. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder. 9\. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections. 10\. Tattoos in the treatment area. 11. Poor skin quality (severe laxity). 12. Abdominal wall, muscular abnormality or hernia on physical examination. 13. Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study. 14\. History of keloid or hypertrophic scar formation or poor wound healing in the treatment area. 15\. As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate. 16\. Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aesthetic Appearance From Baseline | Week 24 | Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale | Week 24 | To assess subject satisfaction with treatment at the Week 24 visit using the 5-point Likert Subject Satisfaction Scale: 0 - very dissatisfied, 1 - dissatisfied, 2 - neutral, 3 - satisfied, 4 - very satisfied. |
| Change in Fat Thickness | Week 24 | Fat thickness was measured using ultrasound at one clinical site (14 subjects in total). Change between Week 0 and Week 24 measurements is shown. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subject Treatment Group Treatment group received 3 diode treatments and 3 RF/PEMF treatments.
Venus Bliss: The FDA-cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, and four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands-free operation. The device uses vacuum-assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Subject Treatment Group |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 8 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Change in Aesthetic Appearance From Baseline
Photographic evaluation by an independent, blinded reviewer with correct identification of pre-treatment baseline images when compared to post-treatment images taken at Week 24 using the Global Aesthetic Improvement Scale (GAIS). A score of 0 is no change, 1 - slight change, 2 - moderate change, 3 - dramatic change. An incorrect identification would result in a negative score (-1 for slight, -2 for moderate and -3 for dramatic change)
Time frame: Week 24
Population: All subjects who had both Week 0 (baseline) and Week 24 (follow-up) photos.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subject Treatment Group | Change in Aesthetic Appearance From Baseline | 0.97 score on a scale | Standard Error 0.08 |
Secondary
Change in Fat Thickness
Fat thickness was measured using ultrasound at one clinical site (14 subjects in total). Change between Week 0 and Week 24 measurements is shown.
Time frame: Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subject Treatment Group | Change in Fat Thickness | -6.9 percentage of baseline | Standard Error 1.1 |
Secondary
Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale
To assess subject satisfaction with treatment at the Week 24 visit using the 5-point Likert Subject Satisfaction Scale: 0 - very dissatisfied, 1 - dissatisfied, 2 - neutral, 3 - satisfied, 4 - very satisfied.
Time frame: Week 24
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subject Treatment Group | Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale | Very Satisfied (4) | 10 Participants |
| Subject Treatment Group | Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale | Satisfied (3) | 11 Participants |
| Subject Treatment Group | Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale | Neutral | 9 Participants |
| Subject Treatment Group | Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale | Dissatisfied | 1 Participants |
| Subject Treatment Group | Subject Satisfaction: 5-Point Likert Subject Satisfaction Scale | Very Dissatisfied | 0 Participants |