Changes in Abdominal Tissues Induced by Magnetic Device - CT Evaluation

NCT ID: NCT03545646

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2019-06-15

Brief Summary

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 four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment.

At the baseline visit, photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the computed tomography and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction 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, 6 and 12 months after the final treatment. Computed tomography and weight measure will be conducted at every follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.

Conditions

Fat Burn

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Treatment with the investigational device - High Intensity Focused ElectroMagnetic System

Group Type: EXPERIMENTAL

Treatment with High Intensity Focused ElectroMagnetic system

Intervention Type: DEVICE

The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.

Interventions

Treatment with High Intensity Focused ElectroMagnetic system

The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment
• Age ≥ 22 years
• Voluntarily signed informed consent form
• BMI ≤ 30 kg/m2

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatologic Surgery Specialists

Macon, Georgia, United States

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

BTL-Abdomen_003

Identifier Type: -

Identifier Source: org_study_id