Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatological Non-Disease
• Intervention / Treatment: Device: BeShape One

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Centro poliklinika
• United States
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic Surgery and Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BeShape One Device Treatment	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Waist Circumference	Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Waist Circumference	Waist circumference change (in cm) following BeShape treatment at the 6 week follow up visits compared to baseline.	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.	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.	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.	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.	Immediately after the treatment procedure at Baseline, up to 5 minutes

Collaborators and Investigators

• Sponsor: BeShape Technologies Ltd.
• Investigators: Study Director: Ahava Stein, A. Stein Regulatory Affairs Consulting Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CTP-BSO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No