N/A
Completed N=515
LAP-BAND AP Early Experience Trial (APEX)
Obesity, Morbid
Source: ClinicalTrials.gov NCT00501085 ↗
Enrolled (actual)
515
Serious AEs
7.4%
Results posted
Jan 2015
Primary outcomePrimary: Change in Percent Excess Weight — -45.7; -50.8; -47.7; -46.5 percentage of excess weight lost
Summary
The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Excess Weight |
-45.7; -50.8; -47.7; -46.5; -45.9 | — |
| SECONDARY Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation |
35.9; 34.8; 35.2; 35.1; 35.2 | — |
| SECONDARY Subject Reported Satiety |
2.1; 2.3; 3.5; 3.3; 2.4; 2.7 | — |
| SECONDARY Subject Reported Quality of Life |
69.8; 34.5 | — |
| SECONDARY Subject Reported Sleepiness (Epworth Sleepiness Scale) |
8.0; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is scheduled to receive the LAP-BAND AP System
- Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.
Exclusion Criteria
- Per the LAP-BAND AP System Directions For Use (DFU)
Data sourced from ClinicalTrials.gov (NCT00501085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.