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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Overweight

Detailed Description

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
• Enrollment (Anticipated): 325

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Surgical Associates
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Illinois Bariatric Center
    • Chicago, Illinois, United States, 60522
      • Bariatric Institute of Greater Chicago
    • Rockford, Illinois, United States, 60522-0084
      • OSF Saint Anthony Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Louisville Surgical Associates
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Surgical Specialists of Louisiana
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Advanced Weight Loss Surgery
  • Missouri
    • Saint Louis, Missouri, United States, 63118
      • St. Alexius New Start
  • New York
    • New York, New York, United States, 10016
      • New York University
  • Ohio
    • Cincinnati, Ohio, United States, 45241
      • Center for Metabolic & Bariatric Surgery
  • Utah
    • Draper, Utah, United States, 84020
      • Utah Lap Band and General Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese adult patients with a BMI ≥ 30 kg/m2 and < 40 kg/m2 with one or more comorbid conditions that have had a LAP-BAND® System implanted.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior bariatric surgery.
2. 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.
3. Vulnerable patients or those unable to exercise free informed consent.
4. Inability to complete the questionnaires.
5. Patients who are addicted to alcohol and/or drugs.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Explants	The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation.	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to the LAP-BAND	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.	5 Years
Diabetes	Assessment of prevalence of diabetes at 5 years	5 Year
Obesity related Comorbidity	Assessment of changes in obesity-related comorbid conditions at Year 5	5 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events	Percentage of patients experiencing reoperations, esophageal dilatation, esophageal dysmotility, and other device-related and procedure-related adverse events observed over the study assessment period.	10 Years

Collaborators and Investigators

• Sponsor: Apollo Endosurgery, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 8, 2018
• Study Completion (Actual): March 8, 2018

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Lap Band
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: Apollo-001