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

Sponsor
Apollo Endosurgery, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02356614
Collaborator
(none)
325
Enrollment
11
Locations
36.2
Duration (Months)
29.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    325 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
    Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Mar 8, 2018
    Actual Study Completion Date :
    Mar 8, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Explants [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.

    Secondary Outcome Measures

    1. Response to the LAP-BAND [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.

    2. Diabetes [5 Year]

      Assessment of prevalence of diabetes at 5 years

    3. Obesity related Comorbidity [5 Year]

      Assessment of changes in obesity-related comorbid conditions at Year 5

    Other Outcome Measures

    1. Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surgical Associates Fountain Valley California United States 92708
    2 Illinois Bariatric Center Champaign Illinois United States 61820
    3 Bariatric Institute of Greater Chicago Chicago Illinois United States 60522
    4 OSF Saint Anthony Medical Center Rockford Illinois United States 60522-0084
    5 Louisville Surgical Associates Louisville Kentucky United States 40215
    6 Surgical Specialists of Louisiana Metairie Louisiana United States 70001
    7 Advanced Weight Loss Surgery Rockville Maryland United States 20850
    8 St. Alexius New Start Saint Louis Missouri United States 63118
    9 New York University New York New York United States 10016
    10 Center for Metabolic & Bariatric Surgery Cincinnati Ohio United States 45241
    11 Utah Lap Band and General Surgery Draper Utah United States 84020

    Sponsors and Collaborators

    • Apollo Endosurgery, Inc.

    Investigators

    • Study Director: Jose L Naveira, Apollo Endosurgery, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Apollo Endosurgery, Inc.
    ClinicalTrials.gov Identifier:
    NCT02356614
    Other Study ID Numbers:
    • Apollo-001
    First Posted:
    Feb 5, 2015
    Last Update Posted:
    Jun 27, 2018
    Last Verified:
    Mar 1, 2018
    Keywords provided by Apollo Endosurgery, Inc.
    Lap Band
    Additional relevant MeSH terms:
    Overweight

    Study Results

    No Results Posted as of Jun 27, 2018