Circumference Reduction
Conditions
Keywords
Circumference reduction
Brief summary
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
Detailed description
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol. Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
Interventions
DEVICEVelaShape III
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
DEVICEUltraShape Power
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent to participate in the study. 2. Female and male subjects, 18 and 60 years of age at the time of enrollment. 3. Fitzpatrick Skin Type I to VI. 4. Fat thickness of at least 1.5 cm (measured by calibrated caliper). 5. BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese). 6. Female subjects must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence). 7. In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with child-bearing potential (e.g. not menopausal). 8. General good health confirmed by medical history and skin examination of the treated area. 9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions. 10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study. 11. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
Exclusion criteria
1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism. 2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease. 3. Having or undergoing any form of treatment for active cancer, or 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. 4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator. 5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone. 6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction. 7. Previous body contouring procedures in the treatment area within 12 months. 8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing. 9. Known photosensitivity. 10. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course. 11. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area. 12. Very poor skin quality (i.e., severe laxity). 13. Abdominal wall diastasis or hernia on physical examination. 14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months. 15. Obesity (BMI \> 30). 16. Pregnant, childbirth within the last 12 months or breastfeeding women. 17. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study. 18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months). 19. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration). 20. Abdominal fat thickness lower than 2.5 cm after strapping. 21. Participation in another clinical study within the last 6 months. 22. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements | At 12 weeks after the third treatment (week 16) for each subject | Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits | At 2, 4, 8 and 12 weeks after baseline | The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline. The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively). Negative change represent reduction in thigh circumference. |
| Investigator Satisfaction | At 4, 8 and 12 weeks follow-up visits | Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment) |
| Subject Satisfaction | At 4, 8 and 12 week follow-up visits | Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VelaShape III & UltraShape Power Subjects received 3 biweekly treatments to the thighs with the VelaShape III and UltraShape Power devices.
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action. | 16 |
| VelaShape III & UltraShape Power Subjects received 3 biweekly treatments to the thighs with the VelaShape III and UltraShape Power devices.
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action. | 32 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | VelaShape III & UltraShape Power |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 46.1 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Mean thigh circumference | 62.1 centimeter STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 16 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
Time frame: At 12 weeks after the third treatment (week 16) for each subject
Population: 6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VelaShape III & UltraShape Power | Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements | -2.8 centimeter | Standard Deviation 1.8 |
Secondary
Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline. The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively). Negative change represent reduction in thigh circumference.
Time frame: At 2, 4, 8 and 12 weeks after baseline
Population: 6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VelaShape III & UltraShape Power | Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits | Circumference change at the second treatment | -0.4 centimeter | Standard Deviation 0.6 |
| VelaShape III & UltraShape Power | Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits | Circumference change at the third treatment | -0.8 centimeter | Standard Deviation 0.7 |
| VelaShape III & UltraShape Power | Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits | Circumference change at 8 weeks after baseline | -1.8 centimeter | Standard Deviation 0.8 |
| VelaShape III & UltraShape Power | Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits | Circumference change at 12 weeks after baseline | -2.2 centimeter | Standard Deviation 1.6 |
Secondary
Investigator Satisfaction
Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)
Time frame: At 4, 8 and 12 weeks follow-up visits
Population: 6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 4 week follow-up | (-2) Very unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 4 week follow-up | (-1) Unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 4 week follow-up | (0) No Opinion | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 4 week follow-up | (1) Satisfied | 5 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 4 week follow-up | (2) Very satisfied | 4 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 8 week follow-up | (-2) Very unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 8 week follow-up | (2) Very satisfied | 5 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 12 week follow-up | (-2) Very unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 12 week follow-up | (-1) Unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 12 week follow-up | (0) No Opinion | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 12 week follow-up | (1) Satisfied | 2 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 8 week follow-up | (-1) Unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 8 week follow-up | (0) No Opinion | 0 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 8 week follow-up | (1) Satisfied | 4 Participants |
| VelaShape III & UltraShape Power | Investigator Satisfaction | Investigator satisfaction at 12 week follow-up | (2) Very satisfied | 7 Participants |
Secondary
Subject Satisfaction
Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).
Time frame: At 4, 8 and 12 week follow-up visits
Population: 6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 12 week follow-up | (-1) Unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 12 week follow-up | (0) No Opinion | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 4 week follow-up | (-2) Very unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 4 week follow-up | (-1) Unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 4 week follow-up | (0) No Opinion | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 4 week follow-up | (1) Satisfied | 3 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 4 week follow-up | (2) Very satisfied | 6 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 8 week follow-up | (-2) Very unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 8 week follow-up | (-1) Unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 8 week follow-up | (0) No Opinion | 1 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 8 week follow-up | (1) Satisfied | 3 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 8 week follow-up | (2) Very satisfied | 5 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 12 week follow-up | (-2) Very unsatisfied | 0 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 12 week follow-up | (1) Satisfied | 2 Participants |
| VelaShape III & UltraShape Power | Subject Satisfaction | Subject satisfaction at 12 week follow-up | (2) Very satisfied | 7 Participants |