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Changes in Abdominal Tissues Induced by Magnetic Device - MRI Evaluation

NCT03545633 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-09-14

No results posted yet for this study

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 three follow-up visits, 2 months, 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 magnetic resonance imaging and the subject's weight will be recorded.

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. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.

Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the final treatment. During those visits, magnetic resonance imaging, photographing and weight measure will be conducted. Subject Satisfaction Questionnaire will be given at every follow-up visit.

Conditions

  • Fat Burn

Interventions

DEVICE

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.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-05-15
Completion
2019-06-15
FDA Device
Yes

Countries

  • United States
  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545633 on ClinicalTrials.gov