Non-invasive Improvement of Buttocks With Magnetic Device

• ClinicalTrials.gov Identifier: NCT03575507
• Recruitment Status: Withdrawn
• First Posted: July 2, 2018
• Last Update Posted: May 27, 2020
• Sponsor: BTL Industries Ltd.
• Information provided by (Responsible Party): BTL Industries Ltd.

Study Description

Brief Summary:

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.

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 Questionnaire 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 will be noted.

Condition or disease	Intervention/treatment	Phase
Muscle Tightness	Device: Treatment with BTL EMSCULPT device.	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Patient Satisfaction With Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Aesthetic Improvements of Buttocks
• Estimated Study Start Date: June 1, 2017
• Estimated Primary Completion Date: September 30, 2018
• Actual Study Completion Date: May 20, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Patient's satisfaction with study treatment for non-invasive aesthetic improvement of buttocks. [ Time Frame: 18 months ]

   Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire.

   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.

Secondary Outcome Measures :

1. Determining side effects and adverse events (AE) associated with the treatment of the gluteal area. [ Time Frame: 18 months ]
   The occurrence of adverse events throughout the whole study.

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Florida

Dr. Mariano Busso Aesthetic Dermatology

Miami, Florida, United States, 33133

Bulgaria

Aesthe Clinic

Sofia, Bulgaria, 1000

Sponsors and Collaborators

BTL Industries Ltd.

More Information

• Responsible Party: BTL Industries Ltd.
• ClinicalTrials.gov Identifier: NCT03575507
• Other Study ID Numbers: BTL-Buttocks_002
• First Posted: July 2, 2018
• Last Update Posted: May 27, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes