Efficacy Study for SD Device

Summary

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

Conditions

• Overweight

Interventions

DEVICE

SD

The participants in the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the device under study (called SD). During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the SD device is done by study participants during the day every day throughout the study period. The device under study can be easily used by the participants themselves in their regular environment and does not require professional assistance. The device under study is expected to affects the satiety, energy homeostasis and metabolic control centers in the brain and by that to reduce food intake and lead to weight loss. The device under study is a device- not a medication and not a surgical procedure, and it does not involve any of such elements.

DEVICE

Control

The participants in the Control arm of the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the placebo. During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the placebo is done by the control study participants during the day every day throughout the study period. The placebo can be easily used by the participants themselves in their regular environment and does not require professional assistance.

DEVICE

SD

The participants in the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the device under study (called SD). During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference. The use of the SD device is done by study participants during the day every day throughout the study period. The device under study can be easily used by the participants themselves in their regular environment and does not require professional assistance. The device under study is expected to affects the satiety, energy homeostasis and metabolic control centers in the brain and by that to reduce food intake and lead to weight loss. The device under study is a device- not a medication and not a surgical procedure, and it does not involve any of such elements.

Sponsors & Collaborators

• Beck Medical Ltd.

  lead INDUSTRY

Principal Investigators

• Dror Dicker, MD · Rabin Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2016-06-30

Completion

2016-12-31

Countries

• Israel

Study Locations