Non-invasive Improvement of Buttocks With Magnetic Device

Sponsor

BTL Industries Ltd. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03575507

Collaborator

(none)

Enrollment

Locations

Arm

35.6

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Tightness	Device: Treatment with BTL EMSCULPT device.	N/A

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

May 20, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Patient's satisfaction with study treatment for non-invasive aesthetic improvement of buttocks. [18 months]
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.

Secondary Outcome Measures

Determining side effects and adverse events (AE) associated with the treatment of the gluteal area. [18 months]
The occurrence of adverse events throughout the whole study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Mariano Busso Aesthetic Dermatology	Miami	Florida	United States	33133
2	Aesthe Clinic	Sofia		Bulgaria	1000

Sponsors and Collaborators

BTL Industries Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BTL Industries Ltd.

ClinicalTrials.gov Identifier:

NCT03575507

Other Study ID Numbers:

BTL-Buttocks_002

First Posted:

Jul 2, 2018

Last Update Posted:

May 27, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of May 27, 2020