Efficacy Study for SD Device

Overweight Clinical Trial

Official title:

Efficacy Study of SD Device for Overweight and Obesity Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01534325
• Other study ID #: BeckMedical-001
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 21, 2016
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Beck Medical Ltd.
• Contact: Beck Medical
• Phone: +972-4-62890779
• Email: adva[@]beckmedical.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

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
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.

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Beck Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No