Clinical trial NCT05896696: Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
Official title: Prospective Clinical Study for the Evaluation of the Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatological Non-Disease
Lead sponsor: BeShape Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline and 6 weeks
measure: Subject Improvement
timeFrame: 6 and 12 weeks
measure: Subject Satisfaction
timeFrame: 6 and 12 weeks
measure: Investigator Satisfaction
timeFrame: 6 and 12 weeks
measure: Subject Comfort/Pain
timeFrame: Immediately after the treatment procedure at Baseline, up to 5 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Vilnius
country: Lithuania
facility: Centro Poliklinika
Study officials:
affiliation: A. Stein Regulatory Affairs Consulting Ltd.
name: Ahava Stein
role: STUDY_DIRECTOR
References: