EasyBand GOAL Trial

Morbid Obesity Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00534339
• Other study ID #: 10042
• Status: Withdrawn
• Phase: N/A
• First received: September 21, 2007
• Last updated: October 3, 2014
• Start date: December 2010
• Est. completion date: February 2016

Study information

• Verified date: November 2010
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum 3 year history of morbid obesity with documented failure of conservative, non-surgical means of weight reduction within 1 year prior to the screening visit;

• BMI >/= 40 kg/m2, or BMI >/= 35 kg/m2 and </= 40 kg/m2 with one or more significant medical conditions related to obesity;

• Candidate for surgical weight loss intervention

Exclusion Criteria:

• Previous surgical treatment of obesity;

• Patient already implanted with a device sensitive to radiofrequency emissions (implantable pacemaker, implantable defibrillator, etc);

• Physical or emotional conditions that may prohibit surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• Easyband (Telemetrically adjustable gastric banding device)
EasyBand

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan Medical

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent excess weight loss (%EWL)		5 years	Yes