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LAP-BAND AP Early Experience Trial (APEX) | Clinical Trials | Clareo Health

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COMPLETEDNCT00501085

LAP-BAND AP Early Experience Trial (APEX)

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

Lead sponsor: Apollo Endosurgery, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Apollo Endosurgery, Inc.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

Exclusion Criteria

•Per the LAP-BAND AP System Directions For Use (DFU)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 19, 2015Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment521

Start dateJun 2007

Last updatedJan 19, 2015

Condition

Obesity, Morbid

Locations shown

Apollo Endosurgery

Austin, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2015Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions