Muscle Tightness Clinical Trial
Official title:
Safety and Patient Satisfaction With Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Aesthetic Improvements of Buttocks
Verified date | May 2020 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 Questionnaire 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 will be noted.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 20, 2020 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 22 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Aesthe Clinic | Sofia | |
United States | Dr. Mariano Busso Aesthetic Dermatology | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States, Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's satisfaction with study treatment for non-invasive aesthetic improvement of buttocks. | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. 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. |
18 months | |
Secondary | Determining side effects and adverse events (AE) associated with the treatment of the gluteal area. | The occurrence of adverse events throughout the whole study. | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05554809 -
Unilateral Stretch Crossover Effect RCT
|
N/A | |
Completed |
NCT05490966 -
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness
|
N/A | |
Completed |
NCT05499338 -
Motivation as a Strategy for Adherence to a Stretching Program for Basketball Players
|
N/A | |
Recruiting |
NCT06074653 -
Effects of Mulligans BLR and CR on Hamstrings Flexibility in Office Workers
|
N/A | |
Completed |
NCT01856972 -
Does the Addition of Manual Therapy Techniques Increase Gastrocnemius/Soleus Length More Than Stretching Alone?
|
N/A | |
Recruiting |
NCT06396741 -
Changes in the Quadriceps Muscle After Dry Needling Treatment
|
N/A | |
Not yet recruiting |
NCT06371547 -
Efficiency of Different Gastrocnemius Stretching Exercises
|
N/A | |
Completed |
NCT05785416 -
Stretching Techniques of Knee Muscles and Their Effect on Joint Range, Suppleness and Muscle Activity in Elderly
|
N/A | |
Not yet recruiting |
NCT05912478 -
Video-Based Game Therapy in Thoracic Hyperkyphosis
|
N/A | |
Completed |
NCT04191759 -
Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device
|
N/A | |
Completed |
NCT06034704 -
Plantar Fascia Release With Magnetic Fascia Ball
|
N/A | |
Completed |
NCT05870904 -
Dry Needling & Trigger Point Compression Release in Neck Pain
|
N/A | |
Completed |
NCT04967898 -
Effect of Manual Technique on Hamstring Flexibility
|
N/A | |
Completed |
NCT05077761 -
Laser Therapy on Hamstring Muscle Among Young Adults
|
N/A | |
Completed |
NCT04571034 -
Effects of Roller Massage on Short-Term Passive Muscle Stiffness
|
N/A | |
Recruiting |
NCT04837287 -
Investigation of the Effect of Different Term Stretching Exercise on Muscle Elasticity in Two Different Muscle Groups
|
N/A | |
Completed |
NCT05611476 -
Cognitive Muscular Therapy for Low Back Pain
|
N/A | |
Completed |
NCT03787979 -
Relative Stiffness of Lumbar Spine and Hamstrings Muscle Stretching
|
N/A | |
Not yet recruiting |
NCT05538598 -
Dry Needling and Muscle Stiffness
|
N/A | |
Withdrawn |
NCT03579147 -
Non-invasive Buttock Lifting Induced by Magnetic Device - Multicentric Study
|
N/A |