A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

Stopped early

Conditions studied: Obesity, Overweight

In brief

This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and \< 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation. The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.

Key facts

Study ID

NCT02356614

Run by

Apollo Endosurgery, Inc.

People needed

325

Starts

2015-03-01

Expected to finish

2018-03-08

Last updated by the study team

2018-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LAP-BAND® System placed in a facility in the United States
• BMI ≥ 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement
• Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement
• Aged 18 or older

You may not qualify if…

• Prior bariatric surgery.
• Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
• Vulnerable patients or those unable to exercise free informed consent.
• Inability to complete the questionnaires.
• Patients who are addicted to alcohol and/or drugs.

Where it is running

• Surgical Associates — Fountain Valley, California, United States
• Illinois Bariatric Center — Champaign, Illinois, United States
• Bariatric Institute of Greater Chicago — Chicago, Illinois, United States
• OSF Saint Anthony Medical Center — Rockford, Illinois, United States
• Louisville Surgical Associates — Louisville, Kentucky, United States
• Surgical Specialists of Louisiana — Metairie, Louisiana, United States
• Advanced Weight Loss Surgery — Rockville, Maryland, United States
• St. Alexius New Start — St Louis, Missouri, United States
• New York University — New York, New York, United States
• Center for Metabolic & Bariatric Surgery — Cincinnati, Ohio, United States
• Utah Lap Band and General Surgery — Draper, Utah, United States

Full record on ClinicalTrials.gov

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