NCT00534339

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
3.2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 7, 2014

Status Verified

November 1, 2010

Enrollment Period

1.3 years

First QC Date

September 21, 2007

Last Update Submit

October 3, 2014

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Percent excess weight loss (%EWL)

    5 years

Interventions

Easyband (Telemetrically adjustable gastric banding device)DEVICE

EasyBand

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

USA, California, United States

Location

Unknown Facility

Canada, Quebec, Canada

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allergan Medical

    Allergan Medical

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

December 1, 2010

Primary Completion

April 1, 2012

Study Completion

February 1, 2016

Last Updated

October 7, 2014

Record last verified: 2010-11

Locations

US(1)CA(1)