A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
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|ClinicalTrials.gov Identifier: NCT02356614|
Recruitment Status : Terminated (Terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.)
First Posted : February 5, 2015
Last Update Posted : June 27, 2018
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.
|Condition or disease|
FDA post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of ≥ 30 kg/m2 and < 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related AEs, and reoperations.
The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was terminated because it was no longer required to fulfill the condition of approval for the device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by using data from published literature and another recently completed study (OSB Lead-Hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.
|Study Type :||Observational|
|Estimated Enrollment :||325 participants|
|Official Title:||A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||March 8, 2018|
|Actual Study Completion Date :||March 8, 2018|
- Percentage of Explants [ Time Frame: 5 Years ]The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation.
- Response to the LAP-BAND [ Time Frame: 5 Years ]Secondary objectives include assessment of patients who respond to the LAP BAND® System at 5 years, where response is defined as achieving at least 7%Total Body Loss (TBL), assessment of prevalence of diabetes at 5 years, and assessment of changes in obesity-related comorbid conditions at 5 years.
- Diabetes [ Time Frame: 5 Year ]Assessment of prevalence of diabetes at 5 years
- Obesity related Comorbidity [ Time Frame: 5 Year ]Assessment of changes in obesity-related comorbid conditions at Year 5
- Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events [ Time Frame: 10 Years ]Percentage of patients experiencing reoperations, esophageal dilatation, esophageal dysmotility, and other device-related and procedure-related adverse events observed over the study assessment period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356614
|United States, California|
|Fountain Valley, California, United States, 92708|
|United States, Illinois|
|Illinois Bariatric Center|
|Champaign, Illinois, United States, 61820|
|Bariatric Institute of Greater Chicago|
|Chicago, Illinois, United States, 60522|
|OSF Saint Anthony Medical Center|
|Rockford, Illinois, United States, 60522-0084|
|United States, Kentucky|
|Louisville Surgical Associates|
|Louisville, Kentucky, United States, 40215|
|United States, Louisiana|
|Surgical Specialists of Louisiana|
|Metairie, Louisiana, United States, 70001|
|United States, Maryland|
|Advanced Weight Loss Surgery|
|Rockville, Maryland, United States, 20850|
|United States, Missouri|
|St. Alexius New Start|
|Saint Louis, Missouri, United States, 63118|
|United States, New York|
|New York University|
|New York, New York, United States, 10016|
|United States, Ohio|
|Center for Metabolic & Bariatric Surgery|
|Cincinnati, Ohio, United States, 45241|
|United States, Utah|
|Utah Lap Band and General Surgery|
|Draper, Utah, United States, 84020|
|Study Director:||Jose L Naveira||Apollo Endosurgery, Inc.|