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

NCT05896696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-10-16

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • BeShape Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Ahava Stein · A. Stein Regulatory Affairs Consulting Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-03-16
Completion
2023-04-27
FDA Device
Yes

Countries

  • United States
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896696 on ClinicalTrials.gov