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 :
Withdrawn
(It was not possible to recruit any patients at that time.)
First Posted : July 6, 2018
Last Update Posted : May 26, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 : | 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 |
| 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. |
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
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
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
| 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 | |
| Responsible Party: | BTL Industries Ltd. |
| ClinicalTrials.gov Identifier: | NCT03579147 |
| Other Study ID Numbers: |
BTL-Buttocks_001 |
| First Posted: | July 6, 2018 Key Record Dates |
| Last Update Posted: | May 26, 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 |