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EasyBand GOAL Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00534339
Enrollment
0
Registered
2007-09-24
Start date
2010-12-31
Completion date
2016-02-29
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief summary

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

Interventions

DEVICEEasyband (Telemetrically adjustable gastric banding device)

EasyBand

Sponsors

Allergan Medical
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percent excess weight loss (%EWL)5 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026