LAP-BAND AP Early Experience Trial (APEX)

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

Total Enrollment

521 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

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Detailed Description

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The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.

Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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LAP-BAND

Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.

LAP-BAND AP Adjustable Gastric Banding System

Intervention Type DEVICE

Reduction of food intake due to creation of smaller stomach pouch.

Interventions

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LAP-BAND AP Adjustable Gastric Banding System

Reduction of food intake due to creation of smaller stomach pouch.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is scheduled to receive the LAP-BAND AP System
* Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.