Obesity
Conditions
Brief summary
A prospective, international, multi-center study of clinical outcomes and estimated healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND AP® Adjustable Gastric Banding System.
Interventions
DEVICELAP-BAND AP® Adjustable Gastric Banding System
The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption.
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
* Patient and investigator have made a decision, independent of the study, to proceed with LAP-BAND AP® implantation. * Male or female aged ≥ 18 years. * BMI ≥ 40 or a BMI ≥ 35 with one or more severe co-morbid conditions, or those who are 45.5 Kg / 100 lbs or more over their estimated ideal weight.
Exclusion criteria
* Prior bariatric surgery. * Type I diabetes patients. * Participating in another ongoing clinical study with concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| %TBWL | 5 years | Percent of total body weight change. |
Countries
Australia, Belgium, Canada, Italy, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LapBand Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System
LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption. | 652 |
| Total | 652 |
Baseline characteristics
| Characteristic | LapBand |
|---|---|
| Age, Customized 18-20 years | 9 Participants |
| Age, Customized 21-29 years | 63 Participants |
| Age, Customized 30-39 years | 164 Participants |
| Age, Customized 40-49 years | 199 Participants |
| Age, Customized 50-59 years | 166 Participants |
| Age, Customized 60+ years | 51 Participants |
| Sex: Female, Male Female | 517 Participants |
| Sex: Female, Male Male | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 652 |
| other Total, other adverse events | 402 / 652 |
| serious Total, serious adverse events | 106 / 652 |
Outcome results
Primary
%TBWL
Percent of total body weight change.
Time frame: 5 years
Population: Patients who attended 5 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LapBand | %TBWL | -18.0 % TBWL | Standard Deviation 12.69 |