Chicago, Illinois 60654

  • Muscle Tightness

Purpose:

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.


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


Study is Available At:


Original ID:

BTL-Buttocks_001


NCT ID:

NCT03579147


Secondary ID:


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

22 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

BTL Industries Ltd.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Study Dates

Start Date:December 15, 2017
Completion Date:September 30, 2019
Completion Type:Anticipated
Primary Completion Date:May 30, 2019
Primary Completion Type:Anticipated
Verification Date:June 2018
Last Changed Date:June 29, 2018
First Received Date:June 19, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Therapy comfort
Time Frame:3 months
Safety Issues:False
Description: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 betwe
Outcome Type:Secondary Outcome
Measure:Occurrence of treatment-related adverse events
Time Frame:13 months
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Effectiveness of the device assessed through Buttocks Evaluation Questionnaire
Time Frame:13 months
Safety Issues:False
Description: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 p
Outcome Type:Primary Outcome
Measure:Subject's satisfaction
Time Frame:13 months
Safety Issues:False
Description: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 a

Study Interventions

Intervention Type:Device
Name:Treatment with BTL EMSCULPT device
Description: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.
Arm Name:Treatment Group

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment Group
Description:Treatment with the investigational device BTL EMSCULPT.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:BTL Industries Ltd.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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