Dermatological Non-DiseaseNCT05896696
Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
A study testing BeShape One in people with Dermatological Non-Disease, run by BeShape Technologies Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatological Non-Disease
- What is being tested?
- BeShape One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Apr 2022to 27 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female and male subjects ≥18 and ≤65 years of age.
- Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
- 18.5 ≤ BMI ≤ 33
- 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.
- Understand the study and volunteer to sign the informed consent.
- Willing to follow the treatment and follow up schedule and post-treatment care instructions.
- Willing to refrain from a change in diet, exercise or medication regimen for the duration of the study.
- Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.
Who cannot join
- Pregnant women, intending to become pregnant during the study, less than 12 months after delivery, breastfeeding, or less than 6 weeks after completing breastfeeding;
- 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.
- 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.
- 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.
- An implanted pacemaker or any other implantable active device anywhere in the body.
- Subjects with thyroid disease and / or metabolic syndrome.
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- Unstable weight within the last 6 months (i.e. + 3% weight change in the past six months).
- Local skin pathologies or natural structure loss in the treated area (hernia) and / or loss of sensation or dysesthesia in the treated area.
- Previous body contouring procedures in the treatment area within the past 12 months.
- History of abdominal surgery, including laparoscopic procedures.
- Caesarean section within 12 months.
- Any permanent or temporary implant in the treatment area such as metal plates or an injected chemical substance such as silicone.
- Actively expressed psychiatric or psychological state.
- Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
- Any condition that, at the researcher's discretion, renders the subject unsuitable for participation in a clinical research study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
About this study
Official title: Prospective Clinical Study for the Evaluation of the Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
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
Read more
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.
Read the 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).
- Conditions
- Dermatological Non-Disease
- Being tested
- BeShape One
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeShape OneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BeShape One Device Treatment | Experimental | Not described Receives: Device: BeShape One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waist Circumference
Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change in Waist Circumference
Waist circumference change (in cm) following BeShape treatment at the 6 week follow up visits compared to baseline.
Measured: Baseline and 6 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: 6 and 12 weeks
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.
Measured: Immediately after the treatment procedure at Baseline, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start28 Apr 2022
- Primary completion16 Mar 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatological Non-DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeShape Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahava Stein, Study director, A. Stein Regulatory Affairs Consulting Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896696
- Sponsor's protocol ID
- CTP-BSO-001
- Status last verified
- Oct 2024
- First submitted
- 17 May 2023
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study for the Evaluation of the Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
- ClinicalTrials.gov ID
- NCT05896696
- Acronym / sponsor ID
- CTP-BSO-001
- Conditions
- Dermatological Non-Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- BeShape Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BeShape One Device Treatment | Experimental | Device: BeShape One |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female and male subjects ≥18 and ≤65 years of age.
- Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
- 18.5 ≤ BMI ≤ 33
- 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.
- Understand the study and volunteer to sign the informed consent.
Key exclusion criteria (15 listed)
- Pregnant women, intending to become pregnant during the study, less than 12 months after delivery, breastfeeding, or less than 6 weeks after completing breastfeeding;
- 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.
- 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.
- 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.
- An implanted pacemaker or any other implantable active device anywhere in the body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeShape OneSingle 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. | Device | BeShape One Device Treatment |
Primary outcome
Change in Waist Circumference
Time frame: Baseline and 12 weeks
Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.
5 secondary outcomes
Change in Waist Circumference
Time frame: Baseline and 6 weeks
Subject Improvement
Time frame: 6 and 12 weeks
Subject Satisfaction
Time frame: 6 and 12 weeks
Investigator Satisfaction
Time frame: 6 and 12 weeks
Subject Comfort/Pain
Time frame: Immediately after the treatment procedure at Baseline, up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahava Stein study director
A. Stein Regulatory Affairs Consulting Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeShape One in people with Dermatological Non-Disease, run by BeShape Technologies Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Waist Circumference (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.