Efficacy Study for SD Device

Beck Medical

Status: Unknown

Conditions: Overweight

Treatments: Device: SD; Device: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534325

BeckMedical-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Study arm

Experimental group

Description:

The Arm who uses the real study device Daily use of SD device

Treatment:

Device: SD

Device: SD

Control Arm

Sham Comparator group

Description:

Daily use of Sham comperator

Treatment:

Device: Control

Staudy2 arm

Experimental group

Description:

Uses the under study device in a different time frames Daily use of SD device in a different time frames than of Study Arm

Treatment:

Device: SD

Device: SD