Non-invasive Buttock Lifting Induced by Magnetic Device - Multicentric Study

Safety and Patient Satisfaction With Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Aesthetic Improvements of Buttocks

This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits - 1 month, 3 months and 12 months after the final treatment. Study will be conducted at several study sites.

At the baseline visit, subject's weight will be recorded. Subjects will receive Buttocks Evaluation Questionnaire to fill in.

The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the gluteal area. Visible contractions will be induced by the device.

At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Subject Satisfaction, Buttocks Evaluation and Therapy Comfort Questionnaires to fill in.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3 months and 12 months after the final treatment. A weight measure will be conducted. Also, subject's satisfaction and buttocks evaluation will be noted.

Study Overview

• Status: Withdrawn
• Conditions: Muscle Tightness
• Intervention / Treatment: Device: Treatment with BTL EMSCULPT device

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1000
    • Aesthe Clinic
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Contour Medical
  • California
    • Beverly Hills, California, United States, 90212
      • Plastic Surgery Excellence
  • Florida
    • Miami, Florida, United States, 33133
      • Dr. Mariano Busso Aesthetic Dermatology
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic Surgery and Dermatology
  • Texas
    • Houston, Texas, United States, 77056
      • Ovation Med Spa
    • Houston, Texas, United States, 77401
      • Refresh Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Voluntarily signed informed consent form
• BMI ≤ 30 kg/m2
• Women of child-bearing potential are required to use birth control measures during the
• whole duration of the study
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

• Cardiac pacemakers
• Electronic implants
• Pulmonary insufficiency
• Metal implants
• Drug pumps
• Haemorrhagic conditions
• Anticoagulation therapy
• Heart disorders
• Malignant tumor
• Fever
• Pregnancy
• Breastfeeding
• Following recent surgical procedures when muscle contraction may disrupt the healing process
• Application over menstruating uterus
• Application over areas of the skin which lack normal sensation
• Scars, open lesions and wounds at the treatment area
• Unrepaired abdominal hernia

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: Treatment Group; Treatment with the investigational device BTL EMSCULPT.	Device: Treatment with BTL EMSCULPT device; The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the buttock area. Visible contractions will be induced by the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's satisfaction	The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers "Agree" and "Strongly agree") in order to claim subject's satisfaction with the therapy outcome.	13 months
Effectiveness of the device assessed through Buttocks Evaluation Questionnaire	The 7 point Likert scale Buttocks Evaluation Questionnaire will be used for an assessment if there is a change in subject's perception of their own buttocks area before and after the therapy session. The total possible score ranges from 4 points (lowest possible satisfaction) to 28 points (highest possible satisfaction).	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of treatment-related adverse events	The secondary objective of the study is to determine side effects and adverse events (AE) associated with the treatment of the abdominal area. The occurrence of adverse events will be followed throughout the whole study.	13 months
Therapy comfort	Therapy comfort will be noted at the last therapy visit. Subjects will be asked to evaluate the agreement with the statement concerning the conformity of the study treatment. Subjects will be evaluating the agreement by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Based on a given answers, the therapy comfort will be calculated.	3 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Anticipated): May 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BTL-Buttocks_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