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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03579147
Recruitment Status : Active, not recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : September 30, 2019

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.




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579147


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

Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03579147     History of Changes
Other Study ID Numbers: BTL-Buttocks_001
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: June 2018
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No