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Fat Reduction Induced by Magnetic Device - Waist Circumference Evaluation

NCT03547934 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL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 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, patient umbilical circumference will be measured 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. Umbilical circumference 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

Interventions

DEVICE

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 NCT03547934 on ClinicalTrials.gov