Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2012-07-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Study arm
The Arm who uses the real study device Daily use of SD 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.
Control Arm
Daily use of Sham comperator
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.
Staudy2 arm
Uses the under study device in a different time frames Daily use of SD device in a different time frames than of Study Arm
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* AGE 18-65 years
Exclusion Criteria
* Type I and II diabetes,
* People with disfunctioning of thyroid gland
* Hypertension
18 Years
65 Years
ALL
No
Sponsors
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Beck Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dror Dicker, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Emek Medical Center
Afula, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BeckMedical-001
Identifier Type: -
Identifier Source: org_study_id
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