LAP-BAND AP Early Experience Trial (APEX)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00501085

Enrollment

521

Registered

2007-07-13

Start date

2007-06-30

Completion date

2013-11-30

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Brief summary

The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

Detailed description

The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.

Interventions

DEVICELAP-BAND AP Adjustable Gastric Banding System

Reduction of food intake due to creation of smaller stomach pouch.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in Percent Excess Weight	Baseline to 5 Years	Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.

Secondary

Measure	Time frame	Description
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation	Baseline to 5 years	Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
Subject Reported Satiety	Baseline to 5 Years	Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.
Subject Reported Quality of Life	Baseline to 5 Years	Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).
Subject Reported Sleepiness (Epworth Sleepiness Scale)	Baseline to 5 years	The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject's level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).

Countries

United States

Participant flow

Pre-assignment details

521 Subjects were enrolled (defined as signing the informed consent). 515 Subjects started treatment and underwent LAP-BAND implantation. 6 Subjects did not have the LAP-BAND implanted after enrolling and signing the informed consent.

Participants by arm

Arm	Count
LAP-BAND Patients who receive the LAP-BAND AP Adjustable Gastric Banding System. LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch.	515
Total	515

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	4
Overall Study	Explantation Surgery	26
Overall Study	Lost to Follow-up	195
Overall Study	Non-Compliance	24
Overall Study	Other loss to follow-up	32
Overall Study	Revision Surgery	7
Overall Study	Study closed by sponsor	109
Overall Study	Subject Decision	1
Overall Study	Withdrawal by Subject	34

Baseline characteristics

Characteristic	LAP-BAND
Age, Continuous	42.7 years STANDARD_DEVIATION 10.89
Age, Customized Median Age	42.7 years
Baseline Excess Weight	118.7 pounds (lbs) STANDARD_DEVIATION 42.46
Baseline Weight	273.9 pounds (lbs) STANDARD_DEVIATION 51.37
Body Mass Index (BMI) at Baseline	44.0 kg/m2 STANDARD_DEVIATION 6.25
Race/Ethnicity, Customized Asian	0 participants
Race/Ethnicity, Customized Black	52 participants
Race/Ethnicity, Customized Caucasian	443 participants
Race/Ethnicity, Customized Hispanic	16 participants
Race/Ethnicity, Customized Missing	1 participants
Race/Ethnicity, Customized Other (Native American or unspecified)	3 participants
Sex: Female, Male Female	422 Participants
Sex: Female, Male Male	93 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	158 / 515
serious Total, serious adverse events	38 / 515

Outcome results

Primary

Change in Percent Excess Weight

Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.

Time frame: Baseline to 5 Years