Efficacy Study for SD Device

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Beck Medical Ltd.
Sponsor:
Information provided by (Responsible Party):
Beck Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01534325
First received: January 12, 2012
Last updated: May 27, 2014
Last verified: May 2014

January 12, 2012
May 27, 2014
July 2012
June 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01534325 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficacy Study for SD Device
Efficacy Study of SD Device for Overweight and Obesity Treatment

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Overweight
  • 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.

  • Experimental: Study arm
    The Arm who uses the real study device
    Intervention: Device: SD
  • Sham Comparator: Control Arm
    Intervention: Device: Control
  • Experimental: Staudy2 arm
    Uses the under study device in a different time frames
    Intervention: Device: SD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Beck Medical +972-4-62890779 adva@beckmedical.com
Israel
 
NCT01534325
BeckMedical-001
Yes
Beck Medical Ltd.
Beck Medical Ltd.
Not Provided
Principal Investigator: Dror Dicker, MD Rabin Medical Center
Beck Medical Ltd.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP