NCT05896696

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: BeShape Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dermatological Non-Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-03-16
• Completion: 2023-04-27
• First posted: 2023-06-09
• Last updated: 2024-10-16
• Results posted: 2024-10-16

Locations

2 sites across 2 countries: United States, Lithuania

Regulatory

• FDA-regulated device study