Clinical trial NCT02356614: A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
Official title: A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Overweight
Keywords: Lap Band
Lead sponsor: Apollo Endosurgery, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Explants
timeFrame: 5 Years
Secondary outcomes:
measure: Response to the LAP-BAND
timeFrame: 5 Years
measure: Diabetes
timeFrame: 5 Year
measure: Obesity related Comorbidity
timeFrame: 5 Year
Other outcomes:
measure: Percent Reoperations, Esophageal Dilatation, esophageal dysmotility, and related adverse events
timeFrame: 10 Years
Locations:
city: Fountain Valley
country: United States
facility: Surgical Associates
state: California
city: Champaign
country: United States
facility: Illinois Bariatric Center
state: Illinois
city: Chicago
country: United States
facility: Bariatric Institute of Greater Chicago
state: Illinois
city: Rockford
country: United States
facility: OSF Saint Anthony Medical Center
state: Illinois
city: Louisville
country: United States
facility: Louisville Surgical Associates
state: Kentucky
city: Metairie
country: United States
facility: Surgical Specialists of Louisiana
state: Louisiana
city: Rockville
country: United States
facility: Advanced Weight Loss Surgery
state: Maryland
city: Saint Louis
country: United States
facility: St. Alexius New Start
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: Cincinnati
country: United States
facility: Center for Metabolic & Bariatric Surgery
state: Ohio
city: Draper
country: United States
facility: Utah Lap Band and General Surgery
state: Utah
Study officials:
affiliation: Apollo Endosurgery, Inc.
name: Jose L Naveira
role: STUDY_DIRECTOR
References: