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The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.
The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population, ages 14 to 17 years. The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAP-BAND | Experimental | All subjects who received the LAP-BAND System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAP-BAND System | Device | Restriction of food intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. | Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Excess Weight Loss Throughout the Study | Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. | Baseline to 5 Years |
| Subject Percent Excess BMI Loss |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
174 participants were enrolled in the study, where enrollment was defined as signing the informed consent form.
21 participants were not implanted after signing the informed consent. 153 participants were treated with the LAP-BAND.
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| ID | Title | Description |
|---|---|---|
| FG000 | LAP-BAND | All subjects who received the LAP-BAND System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The baseline population consisted of all subjects who were implanted with the LAP-BAND System.
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| ID | Title | Description |
|---|---|---|
| BG000 | LAP-BAND | All subjects who received the LAP-BAND System. |
| 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 | Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. | Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years. | Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND). | Number | percentage of participants | 1 year |
|
Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study).
Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of >=1% are reported.
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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 | All subjects who received the LAP-BAND System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Eaton, R.N., BSN, CCRN-R | Apollo Endosurgery | 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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Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement. |
| Baseline to 5 Years |
| Change in Subjects' Comorbid Conditions | The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved. | Baseline to 5 Years |
| Change in Quality of Life Using the Beck Depression Inventory II (BDI) | Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years. | Baseline to 5 Years |
| Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire | Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years. | Baseline to 5 Years |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m2 |
|
| Excess Weight | Excess weight is equal to operative weight minus ideal weight at visit. | Mean | Full Range | pounds (lb) |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Subject Excess Weight Loss Throughout the Study | Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. | Intent to treat (ITT) population with imputation at month 60 | Mean | Standard Deviation | %EWL | Baseline to 5 Years |
|
|
|
| Secondary | Subject Percent Excess BMI Loss | Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement. | Intent to treat (ITT) population with imputation at month 60 | Mean | 95% Confidence Interval | kg/m2 | Baseline to 5 Years |
|
|
|
| Secondary | Change in Subjects' Comorbid Conditions | The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved. | Subjects who had a specific comorbid condition at baseline (Diabetes n=9, Dyslipidemia n=39, Hypertension n=22) | Number | participants whose condition resolved | Baseline to 5 Years |
|
|
|
| Secondary | Change in Quality of Life Using the Beck Depression Inventory II (BDI) | Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years. | Participants who completed the BDI II questionnaire through month 60 | Mean | 95% Confidence Interval | units on BDI scale | Baseline to 5 Years |
|
|
|
| Secondary | Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire | Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years. | Participants who completed the IWQOL Kids questionnaire through month 60 (year 5). | Mean | 95% Confidence Interval | units on IWQOL Kids scale | Baseline to 5 Years |
|
|
|
| 20 |
| 153 |
| 133 |
| 153 |
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Band Slip | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Band erosion | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Esophageal irritation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Esophagus distended | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastric erosion | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastric herniation via Lap-Band | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastric prolapse | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hiatal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intra-abdominal sepsis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Large gastric pouch | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Port Tubing disconnect | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Possible acute obstruction of the Lap-Band | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Recurrent pouch enlargement | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Stomach Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Surgical site infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophageal dilatation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Device failure | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Implant site pain | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
|