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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
Sponsor:
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.

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
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
Estimated 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 : March 2015
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 8, 2018



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Diabetes [ Time Frame: 5 Year ]
    Assessment of prevalence of diabetes at 5 years

  3. Obesity related Comorbidity [ Time Frame: 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 [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, California
Surgical Associates
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
Sponsors and Collaborators
Apollo Endosurgery, Inc.
Investigators
Study Director: Jose L Naveira Apollo Endosurgery, Inc.

Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT02356614     History of Changes
Other Study ID Numbers: Apollo-001
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: March 2018

Keywords provided by Apollo Endosurgery, Inc.:
Lap Band

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms