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

NCT05896696 | Completed Results FDA Device

• 1 other identifier: CTP-BSO-001
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 2

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.

Conditions

Dermatological Non-Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Waist Circumference

  Baseline and 6 weeks

• Subject Improvement

  6 and 12 weeks

• Subject Satisfaction

  6 and 12 weeks

• Investigator Satisfaction

  6 and 12 weeks

• Subject Comfort/Pain

  Immediately after the treatment procedure at Baseline, up to 5 minutes

Study Arms (1)

BeShape One Device Treatment

EXPERIMENTAL

Device: BeShape One

Interventions

BeShape One DEVICE

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.

BeShape One Device Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male subjects ≥18 and ≤65 years of age.
• Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
• ≤ 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BeShape Technologies Ltd.: lead

Study Sites (2)

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

Centro Poliklinika

Vilnius, Lithuania

Location

Results Point of Contact

• Title: Ahava Stein
• Organization: A.Stein Regulatory Affairs Consulting Ltd.

ahava@asteinrac.com

+972-9-7670002

Study Officials

• Ahava Stein

  A. Stein Regulatory Affairs Consulting Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 9, 2023
• Study Start: April 28, 2022
• Primary Completion: March 16, 2023
• Study Completion: April 27, 2023
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); US (1)