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

NCT00948246 | Completed Results

• 1 other identifier: CIP10088
• Study Type: observational
• Target: 112
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility and Ease of Implantation

  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."

  < 1day

Secondary Outcomes (3)

• % Excess Weight Loss

  12 months

• Change in BMI

  12 months

• Change in Weight

  12 months

Study Arms (1)

Easyband

Subjects who had the Easyband device implanted laparoscopically.

Device: Easyband®

Interventions

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.

Easyband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Weight loss clinic and bariatric surgeon clinics within a hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan Medical: lead

Study Sites (4)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Peschiera, Italy

Location

Unknown Facility

Nieuwegein, Netherlands

Location

Unknown Facility

Cheshire, United Kingdom

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Monitor
• Organization: Allergan Medical

devicetrials@allergan.com

(805) 961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 13, 2014
• Results First Posted: November 26, 2012

Record last verified: 2012-10

Locations

GB (1); IT (1); BE (1); NL (1)