Efficacy Study for SD Device

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

Detailed Description
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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.

Official Title
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Efficacy Study of SD Device for Overweight and Obesity Treatment

Conditions
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Overweight

Intervention / Treatment
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* Device: SD
* Device: Control
* Device: SD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>The Arm who uses the real study device Daily use of SD device | Device: SD<br>* 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.<br>|
| Sham Comparator: Control Arm<br>Daily use of Sham comperator | Device: Control<br>* 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.<br>|
| Experimental: Staudy2 arm<br>Uses the under study device in a different time frames Daily use of SD device in a different time frames than of Study Arm | Device: SD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Body Weight | 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. | once in every two weeks up to 13 weeks for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Waist Circumference | 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. | once in every two weeks up to 13 weeks for each participant |