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

• ClinicalTrials.gov Identifier: NCT03579147
• Recruitment Status: Withdrawn
• First Posted: July 6, 2018
• Last Update Posted: May 26, 2020
• Sponsor: BTL Industries Ltd.
• Information provided by (Responsible Party): BTL Industries Ltd.

Tracking Information

• First Submitted Date: June 19, 2018
• First Posted Date: July 6, 2018
• Last Update Posted Date: May 26, 2020
• Actual Study Start Date: December 15, 2017
• Estimated Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 29, 2018)

• Subject's satisfaction [ Time Frame: 13 months ]
  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.
• Effectiveness of the device assessed through Buttocks Evaluation Questionnaire [ Time Frame: 13 months ]
  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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 29, 2018)

• Occurrence of treatment-related adverse events [ Time Frame: 13 months ]
  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.
• Therapy comfort [ Time Frame: 3 months ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Non-invasive Buttock Lifting Induced by Magnetic Device - Multicentric Study
• Official Title: Safety and Patient Satisfaction With Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Aesthetic Improvements of Buttocks

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Muscle Tightness

Intervention

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.

Study Arms

Experimental: Treatment Group

Treatment with the investigational device BTL EMSCULPT.

Intervention: Device: Treatment with BTL EMSCULPT device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 21, 2020): 0
• Original Actual Enrollment (submitted: June 29, 2018): 75
• Estimated Study Completion Date: September 30, 2019
• Estimated Primary Completion Date: May 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, United States

Administrative Information

• NCT Number: NCT03579147
• Other Study ID Numbers: BTL-Buttocks_001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: BTL Industries Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: BTL Industries Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: BTL Industries Ltd.
• Verification Date: May 2020