Efficacy Study for SD Device

Not Applicable

• Conditions: Overweight
• Interventions: Device: SD; Device: Control

• Registration Number: NCT01534325
• Lead Sponsor: Beck Medical Ltd.

Brief Summary

The purpose of this study is to determine whether the SD unique device is effective in treatment of overweight and obesity.

Detailed Description

Obesity and Overweight had become the number 1 health concern of the modern world. Over 1 Billion people worldwide are overweight or obese. Those who suffer from overweight or obesity are exposed to other severe illnesses such as: diabetes, cardiovascular disease and cancer.

Only few drugs and surgeries are currently available as approved treatments for those who wish to reduce weight.

The purpose of this study is to determine whether the SD unique medical device, is effective in treatment of overweight and obesity.

Study Timeline

• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Study Start: 2012-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• BMI 30-41.99
• AGE 18-65 years

Exclusion Criteria

• Pregnant Women,
• Type I and II diabetes,
• People with disfunctioning of thyroid gland
• Hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Staudy2 arm	SD	Uses the under study device in a different time frames Daily use of SD device in a different time frames than of Study Arm
Study arm	SD	The Arm who uses the real study device Daily use of SD device
Control Arm	Control	Daily use of Sham comperator

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Body Weight	once in every two weeks up to 13 weeks for each participant	Each participant's body weight will be measured at his/her beginning of the trial. This measure will become the participant's body weight base-line. Once in every 2 weeks the body weight will be taken again and will be compared to base-line and to previous body weight measures of the participant taken during the study.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Waist Circumference	once in every two weeks up to 13 weeks for each participant	Each participant's Waist circumference will be measured at his/her beginning of the trial. This measure will become the participant's Waist circumference base-line. Once in every 2 weeks the Waist circumference will be taken again and will be compared to base-line and to previous Waist circumference measures of the participant taken during the study.

Trial Locations

Locations (2)

Emek Medical Center; 🇮🇱 Afula, Israel

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel