Efficacy Study for SD Device

This study is currently recruiting participants.

Verified July 2012 by Beck Medical Ltd.

Sponsor:

Information provided by (Responsible Party):

Beck Medical Ltd.

ClinicalTrials.gov Identifier:

NCT01534325

First received: January 12, 2012

Last updated: July 23, 2012

Last verified: July 2012

History of Changes

Purpose

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

Condition	Intervention
Overweight	Device: SD Device: Placebo effect

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Efficacy Study of SD Device for Overweight and Obesity Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Beck Medical Ltd.:

Primary Outcome Measures:

Change from Baseline in Body Weight [ Time Frame: once in every two weeks up to 13 weeks for each participant ] [ Designated as safety issue: No ]
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:

Change from Baseline in Waist Circumference [ Time Frame: once in every two weeks up to 13 weeks for each participant ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	100
Study Start Date:	July 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Study arm The Arm who uses the real study device	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.
Placebo Comparator: Placebo Arm	Device: Placebo effect The participants in the placebo 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 placebo 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.

Arms

Assigned Interventions

Experimental: Study arm

The Arm who uses the real study device

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.

Placebo Comparator: Placebo Arm

Device: Placebo effect

The participants in the placebo 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 placebo 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI 30-39
AGE 18-65 years

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534325

Contacts

Contact: Beck Medical

+972-4-62890779

adva@beckmedical.com

Locations

Israel
Rabin Medical Center	Recruiting
Petach Tikva, Israel, 49100
Contact: Dror Dicker, MD +972-3-9372426 drord@clalit.org.il
Principal Investigator: Dror Dicker, MD

Sponsors and Collaborators

Beck Medical Ltd.

Investigators

Principal Investigator:

Dror Dicker, MD

Rabin Medical Center

More Information

No publications provided

Responsible Party:	Beck Medical Ltd.
ClinicalTrials.gov Identifier:	NCT01534325 History of Changes
Other Study ID Numbers:	BeckMedical-001
Study First Received:	January 12, 2012
Last Updated:	July 23, 2012
Health Authority:	Israel: Ethics Commission

Additional relevant MeSH terms:

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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