Trial Outcomes & Findings for LAP-BAND AP Early Experience Trial (APEX) (NCT NCT00501085)
NCT ID: NCT00501085
Last Updated: 2015-01-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
521 participants
Primary outcome timeframe
Baseline to 5 Years
Results posted on
2015-01-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
515
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
432
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
195
|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
Subject Decision
|
1
|
|
Overall Study
Revision Surgery
|
7
|
|
Overall Study
Explantation Surgery
|
26
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Non-Compliance
|
24
|
|
Overall Study
Study closed by sponsor
|
109
|
|
Overall Study
Other loss to follow-up
|
32
|
Baseline Characteristics
LAP-BAND AP Early Experience Trial (APEX)
Baseline characteristics by cohort
| Measure |
LAP-BAND
n=515 Participants
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.
|
|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Age, Customized
Median Age
|
42.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
422 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
52 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
443 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (Native American or unspecified)
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 participants
n=5 Participants
|
|
Baseline Weight
|
273.9 pounds (lbs)
STANDARD_DEVIATION 51.37 • n=5 Participants
|
|
Body Mass Index (BMI) at Baseline
|
44.0 kg/m2
STANDARD_DEVIATION 6.25 • n=5 Participants
|
|
Baseline Excess Weight
|
118.7 pounds (lbs)
STANDARD_DEVIATION 42.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 YearsPopulation: The analysis population is defined as all subjects treated with the LAP-BAND System.
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.
Outcome measures
| Measure |
LAP-BAND
n=515 Participants
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.
|
|---|---|
|
Change in Percent Excess Weight
%EWL from baseline 48 Weeks Post-Surgery (n=402)
|
-45.7 percentage of excess weight lost
Standard Deviation 21.26
|
|
Change in Percent Excess Weight
%EWL from baseline 24 Months Post-Surgery (n=304)
|
-50.8 percentage of excess weight lost
Standard Deviation 26.70
|
|
Change in Percent Excess Weight
%EWL from baseline 36 Months Post-Surgery (n=226)
|
-47.7 percentage of excess weight lost
Standard Deviation 30.21
|
|
Change in Percent Excess Weight
%EWL from baseline 48 Months Post-Surgery (n=156)
|
-46.5 percentage of excess weight lost
Standard Deviation 27.23
|
|
Change in Percent Excess Weight
%EWL from baseline 60 Months Post-Surgery (n=84)
|
-45.9 percentage of excess weight lost
Standard Deviation 26.80
|
SECONDARY outcome
Timeframe: Baseline to 5 yearsPopulation: The analysis population is defined as all subjects treated with the LAP-BAND System.
Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
Outcome measures
| Measure |
LAP-BAND
n=515 Participants
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.
|
|---|---|
|
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
BMI at 48 Weeks Post-Surgery (n=402)
|
35.9 kg/m2
Standard Deviation 6.39
|
|
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
BMI at 24 Months Post-Surgery (n=304)
|
34.8 kg/m2
Standard Deviation 6.49
|
|
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
BMI at 36 Months Post-Surgery (n=226)
|
35.2 kg/m2
Standard Deviation 6.98
|
|
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
BMI at 48 Months Post-Surgery (n=156)
|
35.1 kg/m2
Standard Deviation 6.20
|
|
Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
BMI at 60 Months Post-Surgery (n=84)
|
35.2 kg/m2
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: Baseline to 5 YearsPopulation: The analysis population is defined as all subjects treated with the LAP-BAND System.
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.
Outcome measures
| Measure |
LAP-BAND
n=515 Participants
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.
|
|---|---|
|
Subject Reported Satiety
Level of Hunger at Baseline (n=487)
|
2.1 units on a scale
Standard Deviation 1.21
|
|
Subject Reported Satiety
Level of Hunger at Month 60 (n=81)
|
2.3 units on a scale
Standard Deviation 1.18
|
|
Subject Reported Satiety
Level of Fullness at Baseline (n=488)
|
3.5 units on a scale
Standard Deviation 1.19
|
|
Subject Reported Satiety
Level of Fullness at Month 60 (n=81)
|
3.3 units on a scale
Standard Deviation 1.29
|
|
Subject Reported Satiety
Level of Desire to Eat at Baseline (n=488)
|
2.4 units on a scale
Standard Deviation 1.19
|
|
Subject Reported Satiety
Level of Desire to Eat at Month 60 (n=81)
|
2.7 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline to 5 YearsPopulation: The analysis population is defined as all subjects treated with the LAP-BAND System.
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).
Outcome measures
| Measure |
LAP-BAND
n=515 Participants
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.
|
|---|---|
|
Subject Reported Quality of Life
OWL-QOL-17 Score at Baseline (n=496)
|
69.8 units on a scale
Standard Deviation 19.98
|
|
Subject Reported Quality of Life
OWL-QOL-17 Score at Month 60 (n=74)
|
34.5 units on a scale
Standard Deviation 24.50
|
SECONDARY outcome
Timeframe: Baseline to 5 yearsPopulation: The analysis population is defined as all subjects treated with the LAP-BAND System.
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).
Outcome measures
| Measure |
LAP-BAND
n=515 Participants
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.
|
|---|---|
|
Subject Reported Sleepiness (Epworth Sleepiness Scale)
Reported Sleepiness at Baseline (n=498)
|
8.0 units on a scale
Standard Deviation 4.23
|
|
Subject Reported Sleepiness (Epworth Sleepiness Scale)
Reported Sleepiness at Month 60 (n=79)
|
5.0 units on a scale
Standard Deviation 3.21
|
Adverse Events
LAP-BAND
Serious events: 38 serious events
Other events: 158 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LAP-BAND
n=515 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.97%
5/515 • Number of events 6 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Surgical and medical procedures
Band erosion
|
0.58%
3/515 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Surgical and medical procedures
Band removal
|
0.58%
3/515 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Surgical and medical procedures
Band Slip
|
2.9%
15/515 • Number of events 16 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Death
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.78%
4/515 • Number of events 4 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Device Malfunction
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Dysphagia
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Fibrous Band Obstruction
|
0.39%
2/515 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastric Erosion
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastric Leak
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastric Prolapse
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastrointestinal Stomal Tumor
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease (GERD)
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Infections and infestations
Infection
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Intra-abdominal Abscess
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Surgical and medical procedures
LapBand Port Revision
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Sepsis
|
0.19%
1/515 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
Other adverse events
| Measure |
LAP-BAND
n=515 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Acid Reflux
|
1.6%
8/515 • Number of events 9 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Band Slip
|
0.78%
4/515 • Number of events 6 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Band too tight
|
1.7%
9/515 • Number of events 19 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.58%
3/515 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.58%
3/515 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Renal and urinary disorders
Cholelithiasis
|
0.97%
5/515 • Number of events 5 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Dilated Gastric Pouch
|
2.3%
12/515 • Number of events 22 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Dysphagia
|
7.2%
37/515 • Number of events 52 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Epigastric pain
|
0.78%
4/515 • Number of events 5 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Flipped Port
|
1.2%
6/515 • Number of events 6 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Food Obstruction
|
0.78%
4/515 • Number of events 4 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease (GERD)
|
2.5%
13/515 • Number of events 17 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Heartburn
|
2.1%
11/515 • Number of events 13 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Increased Restriction
|
1.4%
7/515 • Number of events 7 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Pain at port site
|
1.4%
7/515 • Number of events 7 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
General disorders
Port Tube Leaking
|
0.58%
3/515 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Unable to tolerate solids/liquids
|
1.2%
6/515 • Number of events 9 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Gastrointestinal disorders
Vomiting/Nausea
|
8.2%
42/515 • Number of events 75 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
|
Infections and infestations
Port Site Infection
|
0.58%
3/515 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
|
Additional Information
Laura Eaton, R.N., BSN, CCRN-R
Apollo Endosurgery, Inc.
Phone: 949-468-9301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place