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

NCT03579147 | Withdrawn FDA Device

• 1 other identifier: BTL-Buttocks_001
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 7

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. 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.

Conditions

Muscle Tightness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Occurrence of treatment-related adverse events

  13 months

• Therapy comfort

  3 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Treatment with the investigational device BTL EMSCULPT.

Device: Treatment with BTL EMSCULPT device

Interventions

Treatment with BTL EMSCULPT device 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.

Treatment Group

Eligibility Criteria

• Age: 22 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (7)

Contour Medical

Gilbert, Arizona, 85297, United States

Location

Plastic Surgery Excellence

Beverly Hills, California, 90212, United States

Location

Dr. Mariano Busso Aesthetic Dermatology

Miami, Florida, 33133, United States

Location

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

Ovation Med Spa

Houston, Texas, 77056, United States

Location

Refresh Dermatology

Houston, Texas, 77401, United States

Location

Aesthe Clinic

Sofia, 1000, Bulgaria

Location

MeSH Terms

Interventions

Therapeutics

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: June 19, 2018
• First Posted: July 6, 2018
• Study Start: December 15, 2017
• Primary Completion: May 30, 2019
• Study Completion: September 30, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); US (6)