Obesity, Overweight
Conditions
Keywords
Lap Band
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.
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.
Interventions
None listed
Sponsors
Apollo Endosurgery, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Diabetes | 5 Year | Assessment of prevalence of diabetes at 5 years |
| Obesity related Comorbidity | 5 Year | Assessment of changes in obesity-related comorbid conditions at Year 5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed