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Completed

NCT Number: NCT00948246

European Union (EU) Post-Market Study on Easyband®

The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Demonstrated failure in losing weight with non-invasive therapies
  • BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and < 40 kg/m2 with one or more significant medical conditions related to obesity

Exclusion criteria

  • patients with BMI greater than 60 kg/m2
  • patients who are not indicated for laparoscopic bariatric surgery
  • patients with known allergies to implant materials such as silicone and PEEK
  • patients whose abdominal structures have been damaged during preceding surgical procedures
  • pregnant women
  • patients under the age of 18 years
  • patients treated with steroids
  • patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions
  • patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc

Treatment and study plan

Easyband®

Device

The Easyband adjustable gastric band device is implanted laparoscopically around the top of the stomach to create a small pouch. Adjustments to increase or decrease the stoma size are made non-invasively by telemetric connection between an internal and external antenna.

Primary outcomes

  1. Feasibility and Ease of Implantation

    Time frame: < 1day

    Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is "very easy" and 5 is "impossible."

Secondary outcomes

  1. % Excess Weight Loss

    Time frame: 12 months

    Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.

  2. Change in BMI

    Time frame: 12 months

    Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months

  3. Change in Weight

    Time frame: 12 months

    Change in weight (in kilograms) at baseline to 12 months

Sponsors and collaborators

Lead sponsor

Allergan Medical

Industry

Registry information

Official study title

EU Post-Market Study on Easyband®

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2009
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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