LAP-BAND AP Early Experience Trial (APEX)

Apollo Endosurgery

Status: Completed

Conditions: Obesity, Morbid

Treatments: Device: LAP-BAND AP Adjustable Gastric Banding System

Study type: Observational

Funder types: Industry

Identifiers

NCT00501085

MedAff-LBAP201

Details and patient eligibility

About

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

Full description

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.

Enrollment: 521 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

521 participants in 1 patient group

LAP-BAND

Description:

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

Treatment:

Device: LAP-BAND AP Adjustable Gastric Banding System