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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03579147
Other study ID # BTL-Buttocks_001
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date September 30, 2019

Study information

Verified date May 2020
Source BTL Industries Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 30, 2019
Est. primary completion date May 30, 2019
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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Bulgaria Aesthe Clinic Sofia
United States Plastic Surgery Excellence Beverly Hills California
United States Chicago Cosmetic Surgery and Dermatology Chicago Illinois
United States Contour Medical Gilbert Arizona
United States Ovation Med Spa Houston Texas
United States Refresh Dermatology Houston Texas
United States Dr. Mariano Busso Aesthetic Dermatology Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
BTL Industries Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject's satisfaction 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. 13 months
Primary Effectiveness of the device assessed through Buttocks Evaluation Questionnaire 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). 13 months
Secondary Occurrence of treatment-related adverse events 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.
13 months
Secondary Therapy comfort 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. 3 months
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