Changes in Abdominal Tissues Induced by Magnetic Device - CT Evaluation

NCT03545646 | Withdrawn FDA Device

• 1 other identifier: BTL-Abdomen_003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Abdominal tissues

Outcome Measures

Primary Outcomes (3)

• Effectiveness of the device assessed through photography evaluation

  Photography evaluations with correct identification of pre-treatment images compared to post-treatment images.

  13 months

• Effectiveness of the device assessed through change in adipose/muscle layer thickness

  Change in adipose/muscle layer thickness between pre-treatment and post-treatment based on computed tomography measurements.

  13 months

• 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

Secondary Outcomes (2)

• Safety of the device for non-invasive fat disruption

  13 months

• Therapy comfort

  3 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Treatment with the investigational device - High Intensity Focused ElectroMagnetic System

Device: Treatment with High Intensity Focused ElectroMagnetic system

Interventions

Treatment with High Intensity Focused ElectroMagnetic system 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.

Treatment Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

Dermatologic Surgery Specialists

Macon, Georgia, 31217, United States

Location

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, 60654, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 4, 2018
• Study Start: December 15, 2017
• Primary Completion: May 15, 2019
• Study Completion: June 15, 2019
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)