Trial Outcomes & Findings for Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction (NCT NCT05896696)
NCT ID: NCT05896696
Last Updated: 2024-10-16
Results Overview
Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.
COMPLETED
NA
81 participants
Baseline and 12 weeks
2024-10-16
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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81
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Overall Study
COMPLETED
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72
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Overall Study
NOT COMPLETED
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9
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Screening Failure
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7
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
Baseline characteristics by cohort
| Measure |
BeShape One Device Treatment
n=72 Participants
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.
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|---|---|
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Age, Continuous
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37.29 years
STANDARD_DEVIATION 10.10 • n=5 Participants
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Sex: Female, Male
Female
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53 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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64 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants
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Race (NIH/OMB)
White
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67 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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42 participants
n=5 Participants
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Region of Enrollment
Lithuania
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30 participants
n=5 Participants
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Height
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169.4 cm
STANDARD_DEVIATION 10.12 • n=5 Participants
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Weight
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74.6 kg
STANDARD_DEVIATION 12.71 • n=5 Participants
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BMI
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25.9 kg/m^2
STANDARD_DEVIATION 2.88 • n=5 Participants
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Waist circumference
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90.3 cm
STANDARD_DEVIATION 9.44 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and 12 weeksWaist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.
Outcome measures
| Measure |
BeShape One Device Treatment
n=72 Participants
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.
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|---|---|
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Change in Waist Circumference
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-1.87 cm
Standard Deviation 2.62
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SECONDARY outcome
Timeframe: Baseline and 6 weeksWaist circumference change (in cm) following BeShape treatment at the 6 week follow up visits compared to baseline.
Outcome measures
| Measure |
BeShape One Device Treatment
n=72 Participants
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.
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|---|---|
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Change in Waist Circumference
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-1.22 cm
Standard Deviation 2.06
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SECONDARY outcome
Timeframe: 6 and 12 weeksPopulation: 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
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.
Outcome measures
| Measure |
BeShape One Device Treatment
n=67 Participants
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.
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|---|---|
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Subject Improvement
6 weeks · (3) Very much improved (significant improvement)
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3 Participants
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Subject Improvement
6 weeks · (2) Much improved (moderate improvement)
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8 Participants
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Subject Improvement
6 weeks · (1) Improved (slight improvement)
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27 Participants
|
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Subject Improvement
6 weeks · (0) No change
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27 Participants
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Subject Improvement
6 weeks · (-1) Worse (slightly worse)
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2 Participants
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Subject Improvement
6 weeks · (-2) Moderately Worse
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0 Participants
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Subject Improvement
6 weeks · (-3) Significantly Worse
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0 Participants
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Subject Improvement
12 weeks · (3) Very much improved (significant improvement)
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2 Participants
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Subject Improvement
12 weeks · (2) Much improved (moderate improvement)
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5 Participants
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Subject Improvement
12 weeks · (1) Improved (slight improvement)
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29 Participants
|
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Subject Improvement
12 weeks · (0) No change
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28 Participants
|
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Subject Improvement
12 weeks · (-1) Worse (slightly worse)
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1 Participants
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Subject Improvement
12 weeks · (-2) Moderately Worse
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0 Participants
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Subject Improvement
12 weeks · (-3) Significantly Worse
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0 Participants
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SECONDARY outcome
Timeframe: 6 and 12 weeksPopulation: 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
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.
Outcome measures
| Measure |
BeShape One Device Treatment
n=67 Participants
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.
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|---|---|
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Subject Satisfaction
6 weeks · (2) Very satisfied
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9 Participants
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Subject Satisfaction
6 weeks · 1) Satisfied
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27 Participants
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Subject Satisfaction
6 weeks · (0) No opinion
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25 Participants
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Subject Satisfaction
6 weeks · (-1) Dissatisfied
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6 Participants
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Subject Satisfaction
6 weeks · (-2) Very dissatisfied
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0 Participants
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Subject Satisfaction
12 weeks · (2) Very satisfied
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2 Participants
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Subject Satisfaction
12 weeks · 1) Satisfied
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27 Participants
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Subject Satisfaction
12 weeks · (0) No opinion
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30 Participants
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Subject Satisfaction
12 weeks · (-1) Dissatisfied
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6 Participants
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Subject Satisfaction
12 weeks · (-2) Very dissatisfied
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0 Participants
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SECONDARY outcome
Timeframe: 6 and 12 weeksPopulation: 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
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.
Outcome measures
| Measure |
BeShape One Device Treatment
n=67 Participants
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.
|
|---|---|
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Investigator Satisfaction
6 weeks · (3) Very much improved (significant improvement)
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2 Participants
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Investigator Satisfaction
6 weeks · (2) Much improved (moderate improvement)
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17 Participants
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Investigator Satisfaction
6 weeks · (1) Improved (slight improvement)
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29 Participants
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Investigator Satisfaction
6 weeks · (0) No change
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16 Participants
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Investigator Satisfaction
6 weeks · (-1) Worse (slightly worse)
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3 Participants
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Investigator Satisfaction
6 weeks · (-2) Moderately Worse
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0 Participants
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Investigator Satisfaction
6 weeks · (-3) Significantly Worse
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0 Participants
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Investigator Satisfaction
12 weeks · (3) Very much improved (significant improvement)
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2 Participants
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Investigator Satisfaction
12 weeks · (2) Much improved (moderate improvement)
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12 Participants
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Investigator Satisfaction
12 weeks · (1) Improved (slight improvement)
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33 Participants
|
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Investigator Satisfaction
12 weeks · (0) No change
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17 Participants
|
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Investigator Satisfaction
12 weeks · (-1) Worse (slightly worse)
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1 Participants
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Investigator Satisfaction
12 weeks · (-2) Moderately Worse
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0 Participants
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Investigator Satisfaction
12 weeks · (-3) Significantly Worse
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0 Participants
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SECONDARY outcome
Timeframe: Immediately after the treatment procedure at Baseline, up to 5 minutesSubject 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.
Outcome measures
| Measure |
BeShape One Device Treatment
n=72 Participants
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.
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|---|---|
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Subject Comfort/Pain
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5.14 score on a scale
Standard Deviation 1.73
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Adverse Events
BeShape One Device Treatment
Serious adverse events
| Measure |
BeShape One Device Treatment
n=72 participants at risk
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.
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|---|---|
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Surgical and medical procedures
Laparoscopically assisted hysterectomy
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1.4%
1/72 • Number of events 1 • 12 weeks
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Other adverse events
| Measure |
BeShape One Device Treatment
n=72 participants at risk
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.
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|---|---|
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Infections and infestations
Nasopharyngitis
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1.4%
1/72 • Number of events 1 • 12 weeks
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Psychiatric disorders
Stress
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1.4%
1/72 • Number of events 1 • 12 weeks
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Reproductive system and breast disorders
Uterine leiomyoma
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1.4%
1/72 • Number of events 1 • 12 weeks
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Skin and subcutaneous tissue disorders
Application site bruise / Purpura
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15.3%
11/72 • Number of events 11 • 12 weeks
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Skin and subcutaneous tissue disorders
Erythema
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47.2%
34/72 • Number of events 36 • 12 weeks
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Skin and subcutaneous tissue disorders
Hyperaesthesia
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1.4%
1/72 • Number of events 1 • 12 weeks
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Skin and subcutaneous tissue disorders
Skin Edema
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2.8%
2/72 • Number of events 2 • 12 weeks
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Additional Information
Ahava Stein
A.Stein Regulatory Affairs Consulting Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Institution may not publish the results of the Study, based on information collected or generated by Institution and Principal Investigator without the Sponsor's prior written consent. No publication, presentation in any forum or any other form of disclosure with respect to the Study or the results thereof will be made without Sponsor's prior written consent. The provisions shall apply during the term of the Agreement and for an additional period of 15 years following Study Completion.
- Publication restrictions are in place
Restriction type: OTHER