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The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAP-BAND | Patients who receive the LAP-BAND AP Adjustable Gastric Banding System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAP-BAND AP Adjustable Gastric Banding System | Device | Reduction of food intake due to creation of smaller stomach pouch. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation | Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation. | Baseline to 5 years |
| Subject Reported Satiety |
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Inclusion Criteria:
Exclusion Criteria:
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Community sample
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| Name | Affiliation | Role |
|---|---|---|
| Apollo Endosurgery | Apollo Endosurgery, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apollo Endosurgery | Austin | Texas | 78746 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24328415 | Derived | Ponce J, Taheri S, Lusco V, Cornell C, Ng-Mak DS, Shi R, Okerson T. Efficacy and safety of the adjustable gastric band - pooled interim analysis of the APEX and HERO studies at 48 weeks. Curr Med Res Opin. 2014 May;30(5):841-8. doi: 10.1185/03007995.2013.874992. Epub 2014 Jan 16. | |
| 24328387 | Derived | Fusco M, James S, Cornell C, Okerson T. Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study. Curr Med Res Opin. 2014 May;30(5):849-55. doi: 10.1185/03007995.2013.874991. Epub 2014 Jan 17. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population is defined as the number of subjects who underwent treatment with the LAP-BAND System.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis population is defined as all subjects treated with the LAP-BAND System. | Posted | Mean | Standard Deviation | percentage of excess weight lost | Baseline to 5 Years |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acid Reflux | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Eaton, R.N., BSN, CCRN-R | Apollo Endosurgery, Inc. | 949-468-9301 | laura.eaton@apolloendo.com |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
| Baseline to 5 Years |
| Subject Reported Quality of Life | 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). | Baseline to 5 Years |
| Subject Reported Sleepiness (Epworth Sleepiness Scale) | 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). | Baseline to 5 years |
| 22913906 | Derived | Shayani V, Voellinger D, Liu C, Cornell C, Okerson T. Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012 Jul;124(4):181-8. doi: 10.3810/pgm.2012.07.2561. |
| Revision Surgery |
|
| Explantation Surgery |
|
| Adverse Event |
|
| Non-Compliance |
|
| Study closed by sponsor |
|
| Other loss to follow-up |
|
| years |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Baseline Weight | Mean | Standard Deviation | pounds (lbs) |
|
| Body Mass Index (BMI) at Baseline | Mean | Standard Deviation | kg/m2 |
|
| Baseline Excess Weight | Excess weight is equal to subject weight minus ideal weight (ideal weight is based on having a BMI of 25) | Mean | Standard Deviation | pounds (lbs) |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation | Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation. | The analysis population is defined as all subjects treated with the LAP-BAND System. | Posted | Mean | Standard Deviation | kg/m2 | Baseline to 5 years |
|
|
|
| Secondary | Subject Reported Satiety | 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. | The analysis population is defined as all subjects treated with the LAP-BAND System. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 5 Years |
|
|
|
| Secondary | Subject Reported Quality of Life | 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). | The analysis population is defined as all subjects treated with the LAP-BAND System. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 5 Years |
|
|
|
| Secondary | Subject Reported Sleepiness (Epworth Sleepiness Scale) | 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). | The analysis population is defined as all subjects treated with the LAP-BAND System. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 5 years |
|
|
|
| 38 |
| 515 |
| 158 |
| 515 |
| Band erosion | Surgical and medical procedures | Systematic Assessment |
|
| Band removal | Surgical and medical procedures | Systematic Assessment |
|
| Band Slip | Surgical and medical procedures | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Device Malfunction | General disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Fibrous Band Obstruction | General disorders | Systematic Assessment |
|
| Gastric Erosion | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric Leak | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric Perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric Prolapse | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Stomal Tumor | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Upset | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux Disease (GERD) | Gastrointestinal disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Intra-abdominal Abscess | Gastrointestinal disorders | Systematic Assessment |
|
| LapBand Port Revision | Surgical and medical procedures | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Gastrointestinal disorders | Systematic Assessment |
|
| Band Slip | General disorders | Systematic Assessment |
|
| Band too tight | General disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cholelithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Dilated Gastric Pouch | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Systematic Assessment |
|
| Flipped Port | General disorders | Systematic Assessment |
|
| Food Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux Disease (GERD) | Gastrointestinal disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Increased Restriction | Gastrointestinal disorders | Systematic Assessment |
|
| Pain at port site | General disorders | Systematic Assessment |
|
| Port Tube Leaking | General disorders | Systematic Assessment |
|
| Unable to tolerate solids/liquids | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting/Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Port Site Infection | Infections and infestations | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| BMI at 48 Months Post-Surgery (n=156) |
|
| BMI at 60 Months Post-Surgery (n=84) |
|
|
| Level of Fullness at Month 60 (n=81) |
|
| Level of Desire to Eat at Baseline (n=488) |
|
| Level of Desire to Eat at Month 60 (n=81) |
|