Dermatological Non-Disease
Conditions
Brief summary
The goal of this clinical trial is to evaluate the safety and efficacy of the BeShape One device for non-invasive waist circumference reduction in adults between the ages of 18 and 65. The main question\[s\] it aims to answer are: * reduction in waist circumference following treatment with the BeShape One device at the final 6 and 12-week follow-up visits compared to baseline * Subject improvement and satisfaction * Investigator satisfaction * Subject comfort/pain level Participants will undergo a single treatment with the BeShape One device at the Baseline visit and will return for two follow up visits at 6 and 12 weeks post treatment. Researchers will compare the results at the follow up visits to Baseline.
Detailed description
This study is a prospective, baseline controlled, multi-center, one arm clinical study aimed to assess the efficacy and safety of the BeShape OneTM device for waist circumference reduction. Seventy (70) subjects in two investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. A single treatment utilizing the BeShape OneTM device will be administered. During the follow-up period, visits will be conducted as follows: 6 weeks (6wk FU), and 12 weeks (12wk FU) post treatment. Subject's waist circumference will be measured at baseline (before treatment) and at each of the follow up visits. Circumference reduction will be assessed at each post baseline visit, using a standardized and validated measuring technique. Additionally, investigator and subject assessments will be completed at each follow up visit. Photography of the treatment areas will be performed under visible light conditions of the front, right, left and back view of the subjects at the baseline visit (before first treatment) and at the last follow-up visit (12wk FU).
Interventions
DEVICEBeShape One
Single treatment with the BeShape One device. Participants will receive treatment on at least 4 abdomen/flanks treatment areas and up to 6 treatment areas, at the discretion of the investigator. The subject will receive one treatment on each treatment area.
Sponsors
BeShape Technologies Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female and male subjects ≥18 and ≤65 years of age. 2. Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper). 3. 18.5 ≤ BMI ≤ 33 4. Women of childbearing potential (i.e., not post-menopausal or surgically sterilize) must have a negative urine pregnancy test. Participating women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to enrollment. 5. Understand the study and volunteer to sign the informed consent. 6. Willing to follow the treatment and follow up schedule and post-treatment care instructions. 7. Willing to refrain from a change in diet, exercise or medication regimen for the duration of the study. 8. Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.
Exclusion criteria
1. Pregnant women, intending to become pregnant during the study, less than 12 months after delivery, breastfeeding, or less than 6 weeks after completing breastfeeding; 2. Participation in another clinical study of another investigational device or drug involving the same anatomical site within the last 3 months, or, if it does not involve the same anatomical site, at the discretion of the researcher. 3. Subjects with significant systemic disease, such as ongoing hyperlipidemia, diabetes mellitus, hepatitis or other liver disease, HIV-positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease, and malignant neoplasms; undergoing chronic steroid or immunosuppressive therapy. 4. Subject 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. 5. An implanted pacemaker or any other implantable active device anywhere in the body. 6. Subjects with thyroid disease and / or metabolic syndrome. 7. Unstable weight within the last 6 months (i.e. + 3% weight change in the past six months). 8. Local skin pathologies or natural structure loss in the treated area (hernia) and / or loss of sensation or dysesthesia in the treated area. 9. Previous body contouring procedures in the treatment area within the past 12 months. 10. History of abdominal surgery, including laparoscopic procedures. 11. Caesarean section within 12 months. 12. Any permanent or temporary implant in the treatment area such as metal plates or an injected chemical substance such as silicone. 13. Actively expressed psychiatric or psychological state. 14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months. 15. Any condition that, at the researcher's discretion, renders the subject unsuitable for participation in a clinical research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | Baseline and 12 weeks | Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | Baseline and 6 weeks | Waist circumference change (in cm) following BeShape treatment at the 6 week follow up visits compared to baseline. |
| Subject Improvement | 6 and 12 weeks | Subject improvement is measured using the Global Aesthetic Improvement (GAI) scale at each follow up visit. The GAI scale is a 7 point scale ranging from significantly worse (-3) to significant improvement (+3). A higher GAI score indicates a greater improvement. |
| Subject Satisfaction | 6 and 12 weeks | Subject satisfaction is measured using a 5 point Likert scale at each follow up visit. The 5 point Likert scale ranges from very dissatisfied (-2) to very satisfied (+2). A higher score indicates greater subject satisfaction. |
| Investigator Satisfaction | 6 and 12 weeks | Investigator satisfaction is measuring using the Clinical Global Aesthetic Improvement (CGAI) scale at each follow up visit. The CGAI scale is a 7 point scale ranging from significantly worse (-3) to significant improvement (+3). A higher CGAI score indicates a greater improvement. |
| Subject Comfort/Pain | Immediately after the treatment procedure at Baseline, up to 5 minutes | Subject comfort/pain level will be assessed immediately after treatment using the Numeric Pain Rating Scale (NPRS). The NPRS scale is a 10 point scale ranging from 0 (no pain) to 10 (worst possible pain). A higher NPRS score indicates a greater pain level. |
Countries
Lithuania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BeShape One Device Treatment BeShape One: Single treatment with the BeShape One device. Participants will receive treatment on at least 4 abdomen/flanks treatment areas and up to 6 treatment areas, at the discretion of the investigator. The subject will receive one treatment on each treatment area. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screening Failure | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | BeShape One Device Treatment |
|---|---|
| Age, Continuous | 37.29 years STANDARD_DEVIATION 10.1 |
| BMI | 25.9 kg/m^2 STANDARD_DEVIATION 2.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 169.4 cm STANDARD_DEVIATION 10.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 67 Participants |
| Region of Enrollment Lithuania | 30 participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 19 Participants |
| Waist circumference | 90.3 cm STANDARD_DEVIATION 9.44 |
| Weight | 74.6 kg STANDARD_DEVIATION 12.71 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 72 |
| other Total, other adverse events | 47 / 72 |
| serious Total, serious adverse events | 1 / 72 |
Outcome results
Primary
Change in Waist Circumference
Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BeShape One Device Treatment | Change in Waist Circumference | -1.87 cm | Standard Deviation 2.62 |
p-value: <0.000195% CI: [-2.49, -1.26]Paired sample t-test
Secondary
Change in Waist Circumference
Waist circumference change (in cm) following BeShape treatment at the 6 week follow up visits compared to baseline.
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BeShape One Device Treatment | Change in Waist Circumference | -1.22 cm | Standard Deviation 2.06 |
p-value: <0.000195% CI: [-1.7, -0.73]paired sample t-test
Secondary
Investigator Satisfaction
Investigator satisfaction is measuring using the Clinical Global Aesthetic Improvement (CGAI) scale at each follow up visit. The CGAI scale is a 7 point scale ranging from significantly worse (-3) to significant improvement (+3). A higher CGAI score indicates a greater improvement.
Time frame: 6 and 12 weeks
Population: Five (5) participants did not complete the 6 weeks follow-up (FU) visit and seven (7) participants did not complete their 12 weeks FU visit. Reasons for not completing the follow up visits: 4 participants were lost to follow up (2 did not return for the 6 and 12 week FU visit and 2 did not return only for the 12 week FU visit), 1 participant became pregnant after the treatment and was dropped from the study and 2 participants did not complete the treatment and therefore did not return for FU
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (3) Very much improved (significant improvement) | 2 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (2) Much improved (moderate improvement) | 17 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (1) Improved (slight improvement) | 29 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (0) No change | 16 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (-1) Worse (slightly worse) | 3 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (-2) Moderately Worse | 0 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 6 weeks | (-3) Significantly Worse | 0 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (3) Very much improved (significant improvement) | 2 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (2) Much improved (moderate improvement) | 12 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (1) Improved (slight improvement) | 33 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (0) No change | 17 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (-1) Worse (slightly worse) | 1 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (-2) Moderately Worse | 0 Participants |
| BeShape One Device Treatment | Investigator Satisfaction | 12 weeks | (-3) Significantly Worse | 0 Participants |
Secondary
Subject Comfort/Pain
Subject comfort/pain level will be assessed immediately after treatment using the Numeric Pain Rating Scale (NPRS). The NPRS scale is a 10 point scale ranging from 0 (no pain) to 10 (worst possible pain). A higher NPRS score indicates a greater pain level.
Time frame: Immediately after the treatment procedure at Baseline, up to 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BeShape One Device Treatment | Subject Comfort/Pain | 5.14 score on a scale | Standard Deviation 1.73 |
Secondary
Subject Improvement
Subject improvement is measured using the Global Aesthetic Improvement (GAI) scale at each follow up visit. The GAI scale is a 7 point scale ranging from significantly worse (-3) to significant improvement (+3). A higher GAI score indicates a greater improvement.
Time frame: 6 and 12 weeks
Population: Five (5) participants did not complete the 6 weeks follow-up (FU) visit and seven (7) participants did not complete their 12 weeks FU visit. Reasons for not completing the follow up visits: 4 participants were lost to follow up (2 did not return for the 6 and 12 week FU visit and 2 did not return only for the 12 week FU visit), 1 participant became pregnant after the treatment and was dropped from the study and 2 participants did not complete the treatment and therefore did not return for FU
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (3) Very much improved (significant improvement) | 3 Participants |
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (2) Much improved (moderate improvement) | 8 Participants |
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (1) Improved (slight improvement) | 27 Participants |
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (0) No change | 27 Participants |
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (-1) Worse (slightly worse) | 2 Participants |
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (-2) Moderately Worse | 0 Participants |
| BeShape One Device Treatment | Subject Improvement | 6 weeks | (-3) Significantly Worse | 0 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (3) Very much improved (significant improvement) | 2 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (2) Much improved (moderate improvement) | 5 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (1) Improved (slight improvement) | 29 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (0) No change | 28 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (-1) Worse (slightly worse) | 1 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (-2) Moderately Worse | 0 Participants |
| BeShape One Device Treatment | Subject Improvement | 12 weeks | (-3) Significantly Worse | 0 Participants |
Secondary
Subject Satisfaction
Subject satisfaction is measured using a 5 point Likert scale at each follow up visit. The 5 point Likert scale ranges from very dissatisfied (-2) to very satisfied (+2). A higher score indicates greater subject satisfaction.
Time frame: 6 and 12 weeks
Population: Five (5) participants did not complete the 6 weeks follow-up (FU) visit and seven (7) participants did not complete their 12 weeks FU visit. Reasons for not completing the follow up visits: 4 participants were lost to follow up (2 did not return for the 6 and 12 week FU visit and 2 did not return only for the 12 week FU visit), 1 participant became pregnant after the treatment and was dropped from the study and 2 participants did not complete the treatment and therefore did not return for FU
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| BeShape One Device Treatment | Subject Satisfaction | 6 weeks | (2) Very satisfied | 9 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 6 weeks | 1) Satisfied | 27 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 6 weeks | (0) No opinion | 25 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 6 weeks | (-1) Dissatisfied | 6 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 6 weeks | (-2) Very dissatisfied | 0 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 12 weeks | (2) Very satisfied | 2 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 12 weeks | 1) Satisfied | 27 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 12 weeks | (0) No opinion | 30 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 12 weeks | (-1) Dissatisfied | 6 Participants |
| BeShape One Device Treatment | Subject Satisfaction | 12 weeks | (-2) Very dissatisfied | 0 Participants |