Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LAP-BAND AP Early Experience Trial (APEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501085
Recruitment Status : Completed
First Posted : July 13, 2007
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Obesity, Morbid
Intervention Device: LAP-BAND AP Adjustable Gastric Banding System
Enrollment 521
Recruitment Details  
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.
Arm/Group Title LAP-BAND
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 515 [1]
Completed 83 [2]
Not Completed 432
Reason Not Completed
Lost to Follow-up             195
Withdrawal by Subject             34
Subject Decision             1
Revision Surgery             7
Explantation Surgery             26
Adverse Event             4
Non-Compliance             24
Study closed by sponsor             109
Other loss to follow-up             32
[1]
Number of participants who were treated with the LAP-BAND System.
[2]
Number of participants completing 5 year follow-up visit.
Arm/Group Title LAP-BAND
Hide Arm/Group Description

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 Number of Baseline Participants 515
Hide Baseline Analysis Population Description
The analysis population is defined as the number of subjects who underwent treatment with the LAP-BAND System.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 515 participants
42.7  (10.89)
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Median Age Number Analyzed 515 participants
42.7
(18.5 to 70.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants
Female
422
  81.9%
Male
93
  18.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 515 participants
Asian 0
Black 52
Hispanic 16
Caucasian 443
Other (Native American or unspecified) 3
Missing 1
Baseline Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds (lbs)
Number Analyzed 515 participants
273.9  (51.37)
Body Mass Index (BMI) at Baseline  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 515 participants
44.0  (6.25)
Baseline Excess Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Pounds (lbs)
Number Analyzed 515 participants
118.7  (42.46)
[1]
Measure Description: Excess weight is equal to subject weight minus ideal weight (ideal weight is based on having a BMI of 25)
1.Primary Outcome
Title Change in Percent Excess Weight
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is defined as all subjects treated with the LAP-BAND System.
Arm/Group Title LAP-BAND
Hide Arm/Group Description:

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 Number of Participants Analyzed 515
Mean (Standard Deviation)
Unit of Measure: percentage of excess weight lost
%EWL from baseline 48 Weeks Post-Surgery (n=402) -45.7  (21.26)
%EWL from baseline 24 Months Post-Surgery (n=304) -50.8  (26.70)
%EWL from baseline 36 Months Post-Surgery (n=226) -47.7  (30.21)
%EWL from baseline 48 Months Post-Surgery (n=156) -46.5  (27.23)
%EWL from baseline 60 Months Post-Surgery (n=84) -45.9  (26.80)
2.Secondary Outcome
Title Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
Hide Description Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is defined as all subjects treated with the LAP-BAND System.
Arm/Group Title LAP-BAND
Hide Arm/Group Description:

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 Number of Participants Analyzed 515
Mean (Standard Deviation)
Unit of Measure: kg/m2
BMI at 48 Weeks Post-Surgery (n=402) 35.9  (6.39)
BMI at 24 Months Post-Surgery (n=304) 34.8  (6.49)
BMI at 36 Months Post-Surgery (n=226) 35.2  (6.98)
BMI at 48 Months Post-Surgery (n=156) 35.1  (6.20)
BMI at 60 Months Post-Surgery (n=84) 35.2  (6.49)
3.Secondary Outcome
Title Subject Reported Satiety
Hide Description 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.
Time Frame Baseline to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is defined as all subjects treated with the LAP-BAND System.
Arm/Group Title LAP-BAND
Hide Arm/Group Description:

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 Number of Participants Analyzed 515
Mean (Standard Deviation)
Unit of Measure: units on a scale
Level of Hunger at Baseline (n=487) 2.1  (1.21)
Level of Hunger at Month 60 (n=81) 2.3  (1.18)
Level of Fullness at Baseline (n=488) 3.5  (1.19)
Level of Fullness at Month 60 (n=81) 3.3  (1.29)
Level of Desire to Eat at Baseline (n=488) 2.4  (1.19)
Level of Desire to Eat at Month 60 (n=81) 2.7  (1.19)
4.Secondary Outcome
Title Subject Reported Quality of Life
Hide Description 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).
Time Frame Baseline to 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is defined as all subjects treated with the LAP-BAND System.
Arm/Group Title LAP-BAND
Hide Arm/Group Description:

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 Number of Participants Analyzed 515
Mean (Standard Deviation)
Unit of Measure: units on a scale
OWL-QOL-17 Score at Baseline (n=496) 69.8  (19.98)
OWL-QOL-17 Score at Month 60 (n=74) 34.5  (24.50)
5.Secondary Outcome
Title Subject Reported Sleepiness (Epworth Sleepiness Scale)
Hide Description 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).
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is defined as all subjects treated with the LAP-BAND System.
Arm/Group Title LAP-BAND
Hide Arm/Group Description:

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 Number of Participants Analyzed 515
Mean (Standard Deviation)
Unit of Measure: units on a scale
Reported Sleepiness at Baseline (n=498) 8.0  (4.23)
Reported Sleepiness at Month 60 (n=79) 5.0  (3.21)
Time Frame Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Adverse Event Reporting Description Adverse Event data was collected for the analysis population, defined as all subjects treated with the LAP-BAND System (N=515)
 
Arm/Group Title LAP-BAND
Hide Arm/Group Description

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.

All-Cause Mortality
LAP-BAND
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LAP-BAND
Affected / at Risk (%) # Events
Total   38/515 (7.38%)    
Gastrointestinal disorders   
Abdominal pain   5/515 (0.97%)  6
Dysphagia   1/515 (0.19%)  1
Gastric Erosion   1/515 (0.19%)  1
Gastric Leak   1/515 (0.19%)  1
Gastric Perforation   1/515 (0.19%)  1
Gastric Prolapse   1/515 (0.19%)  1
Gastrointestinal Stomal Tumor   1/515 (0.19%)  1
Gastrointestinal Upset   1/515 (0.19%)  1
Gastroesophageal Reflux Disease (GERD)   1/515 (0.19%)  1
Intra-abdominal Abscess   1/515 (0.19%)  1
Nausea/Vomiting   1/515 (0.19%)  1
Pancreatitis   1/515 (0.19%)  1
Sepsis   1/515 (0.19%)  1
General disorders   
Death   1/515 (0.19%)  1
Device Malfunction   1/515 (0.19%)  1
Fibrous Band Obstruction   2/515 (0.39%)  2
Infections and infestations   
Infection   1/515 (0.19%)  1
Metabolism and nutrition disorders   
Dehydration   4/515 (0.78%)  4
Surgical and medical procedures   
Band erosion   3/515 (0.58%)  3
Band removal   3/515 (0.58%)  3
Band Slip   15/515 (2.91%)  16
LapBand Port Revision   1/515 (0.19%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
LAP-BAND
Affected / at Risk (%) # Events
Total   158/515 (30.68%)    
Gastrointestinal disorders   
Acid Reflux   8/515 (1.55%)  9
Dilated Gastric Pouch   12/515 (2.33%)  22
Dysphagia   37/515 (7.18%)  52
Epigastric pain   4/515 (0.78%)  5
Food Obstruction   4/515 (0.78%)  4
Gastroesophageal Reflux Disease (GERD)   13/515 (2.52%)  17
Heartburn   11/515 (2.14%)  13
Increased Restriction   7/515 (1.36%)  7
Unable to tolerate solids/liquids   6/515 (1.17%)  9
Vomiting/Nausea   42/515 (8.16%)  75
General disorders   
Band Slip   4/515 (0.78%)  6
Band too tight   9/515 (1.75%)  19
Flipped Port   6/515 (1.17%)  6
Pain at port site   7/515 (1.36%)  7
Port Tube Leaking   3/515 (0.58%)  3
Infections and infestations   
Port Site Infection   3/515 (0.58%)  3
Renal and urinary disorders   
Cholelithiasis   5/515 (0.97%)  5
Respiratory, thoracic and mediastinal disorders   
Chest Pain   3/515 (0.58%)  3
Skin and subcutaneous tissue disorders   
Cellulitis   3/515 (0.58%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Eaton, R.N., BSN, CCRN-R
Organization: Apollo Endosurgery, Inc.
Phone: 949-468-9301
EMail: laura.eaton@apolloendo.com
Layout table for additonal information
Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT00501085     History of Changes
Other Study ID Numbers: MedAff-LBAP201
First Submitted: July 11, 2007
First Posted: July 13, 2007
Results First Submitted: January 8, 2015
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015