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
  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: Control

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:


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: December 2016
Estimated Primary Completion Date: June 2016 (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.

Sham Comparator: Control Arm 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.

Experimental: Staudy2 arm
Uses the under study device in a different time frames
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.


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 30-41.99
  • AGE 18-65 years

Exclusion Criteria:

  • Pregnant Women,
  • Type I and II diabetes,
  • People with disfunctioning of thyroid gland
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Beck Medical +972-4-62890779 adva@beckmedical.com

Locations
Israel
Emek Medical Center Recruiting
Afula, Israel
Contact: Arie Markel, MD    +972-4-64943400    markel_ar@clalit.org.il   
Principal Investigator: Arie Markel, MD         
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: May 27, 2014
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014