Clinical trial NCT03579147: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Muscle Tightness
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Subject's satisfaction
timeFrame: 13 months
measure: Effectiveness of the device assessed through Buttocks Evaluation Questionnaire
timeFrame: 13 months
Secondary outcomes:
measure: Occurrence of treatment-related adverse events
timeFrame: 13 months
measure: Therapy comfort
timeFrame: 3 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Contour Medical
state: Arizona
city: Beverly Hills
country: United States
facility: Plastic Surgery Excellence
state: California
city: Miami
country: United States
facility: Dr. Mariano Busso Aesthetic Dermatology
state: Florida
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology
state: Illinois
city: Houston
country: United States
facility: Ovation Med Spa
state: Texas
city: Houston
country: United States
facility: Refresh Dermatology
state: Texas
city: Sofia
country: Bulgaria
facility: Aesthe Clinic
Study officials:
References: