EasyBand GOAL Trial | NCT00534339

Studies
EasyBand GOAL Trial

NCT00534339

Sponsor

Allergan Medical

Status

Withdrawn

Last Update Posted

Oct 7, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

Easyband (Telemetrically adjustable gastric banding device)

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was withdrawn to further optimize the device. No patients were enrolled in the trial.

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Apr 2012Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Sep 21, 2007

First Submission Date that Met QC Criteria

Sep 21, 2007

First Posted Date

Sep 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2014

Last Update Posted Date

Oct 7, 2014Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Easyband (Telemetrically adjustable gastric banding device)	Device	EasyBand

Measure	Description	Time Frame
Percent excess weight loss (%EWL)		5 years

Eligibility Module

Eligibility Criteria

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 \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Allergan Medical	Allergan Medical	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		USA	California		United States