Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2.

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Detailed Description

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LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LapBand

All subjects who receive the LAP-BAND System.

Group Type EXPERIMENTAL

LAP-BAND System

Intervention Type DEVICE

Reduction of food intake due to creation of smaller stomach pouch

Interventions

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LAP-BAND System

Reduction of food intake due to creation of smaller stomach pouch

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have a BMI ≥ 30 kg/m2 and \< 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and \< 40 kg/m2 without severe comorbid conditions
* Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs

Exclusion Criteria

* Subject history of congenital or acquired anomalies of the gastrointestinal tract
* Severe cardiopulmonary or other serious or uncontrolled organic disease
* Severe coagulopathy; hepatic insufficiency or cirrhosis
* History of bariatric; gastric; or esophageal surgery
* History of intestinal obstruction or adhesive peritonitis
* History of esophageal dysmotility disorders
* Type I diabetes

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No