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| ID | Type | Description | Link |
|---|---|---|---|
| G050010 | Other Identifier | H 11876 |
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| Name | Class |
|---|---|
| Hope Foundation | OTHER |
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This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.
STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).
DESIGN:Prospective, open-label, and single center
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lap-Band | Experimental | Lap-band surgery in treatment of morbidly obese adolescents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lap-Band | Device | Obesity and adolescents |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Excess Weight Loss (EWL) | Year 1 | |
| Percentage of Excess Weight Loss (EWL) | Year 2 | |
| Percentage of Excess Weight Loss (EWL) | Year 3 | |
| Percentage of Excess Weight Loss (EWL) | Year 4 | |
| Percentage of Excess Weight Loss (EWL) | Year 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | Year 1 | |
| Body Mass Index (BMI) | Year 2 | |
| Body Mass Index (BMI) |
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Inclusion Criteria:
Express willingness to follow protocol requirements.
•Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Ren-Fielding, M.D. | NYUSOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| Label | URL |
|---|---|
| NYU Program for Surgical Weight Loss | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lap-Band | Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lap-Band | Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents |
| 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 | Percentage of Excess Weight Loss (EWL) | Posted | Mean | Standard Deviation | percentage of EWL | Year 1 |
|
|
5 years
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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 | Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pannus (excess skin) | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Ren Fielding, MD | NYU Langone Health | 2122633166 | christine.ren-fielding@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2016 | Dec 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Year 3 |
| Body Mass Index (BMI) | Year 4 |
| Body Mass Index (BMI) | Year 5 |
| Protocol Violation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Body Mass Index (BMI) | Posted | Mean | Standard Deviation | kg/m^2 | Year 1 |
|
|
|
| Primary | Percentage of Excess Weight Loss (EWL) | Posted | Mean | Standard Deviation | percentage of EWL | Year 2 |
|
|
|
| Primary | Percentage of Excess Weight Loss (EWL) | Posted | Mean | Standard Deviation | percentage of EWL | Year 3 |
|
|
|
| Primary | Percentage of Excess Weight Loss (EWL) | Posted | Mean | Standard Deviation | percentage of EWL | Year 4 |
|
|
|
| Primary | Percentage of Excess Weight Loss (EWL) | Posted | Mean | Standard Deviation | percentage of EWL | Year 5 |
|
|
|
| Secondary | Body Mass Index (BMI) | Posted | Mean | Standard Deviation | kg/m^2 | Year 2 |
|
|
|
| Secondary | Body Mass Index (BMI) | Posted | Mean | Standard Deviation | kg/m^2 | Year 3 |
|
|
|
| Secondary | Body Mass Index (BMI) | Posted | Mean | Standard Deviation | kg/m^2 | Year 4 |
|
|
|
| Secondary | Body Mass Index (BMI) | Posted | Mean | Standard Deviation | kg/m^2 | Year 5 |
|
|
|
| 0 |
| 119 |
| 24 |
| 119 |
| 99 |
| 119 |
| Band erosion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Band slippage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cholelithiasis (Aggravated) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophageal and gastric pouch dilatation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric pouch dilatation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Left tibia surgery for Blount's disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Perforated appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Port leak | General disorders | Non-systematic Assessment |
|
| Pregnancy with abortion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Right tibia surgery for Blount's disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Abdominal subcutaneous infection | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abnormal EKG (junctional bradycardia) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acne | Endocrine disorders | Non-systematic Assessment |
|
| Acute dysphagia | General disorders | Non-systematic Assessment |
|
| ADD | General disorders | Non-systematic Assessment |
|
| ADHD | General disorders | Non-systematic Assessment |
|
| Adnexal mass | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Adrenal Hyperplasia | General disorders | Non-systematic Assessment |
|
| Anemia | General disorders | Non-systematic Assessment |
|
| Anorexia | General disorders | Non-systematic Assessment |
|
| Anxiety | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety Attack | Nervous system disorders | Non-systematic Assessment |
|
| ARD (Acute Respiratory Failure) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Back pain | General disorders | Non-systematic Assessment |
|
| Band erosion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Band intolerance | Gastrointestinal disorders | Non-systematic Assessment |
|
| Band intolerance (Chronic dysphagia) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Band slippage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Behavioural issue | General disorders | Non-systematic Assessment |
|
| Bell's palsy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Cholelithiasis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chronic band intolerance | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chronic dysphagia with band tightening | Gastrointestinal disorders | Non-systematic Assessment |
|
| Common cold | General disorders | Non-systematic Assessment |
|
| Depression | General disorders | Non-systematic Assessment |
|
| Depression (Aggravated) | General disorders | Non-systematic Assessment |
|
| Device malfunction (Band aneurysm) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dilated esophagus and gastric pouch | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dsyphagia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dyslipidemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Dyslipidemia (Aggravated) | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysphagia | General disorders | Non-systematic Assessment |
|
| Dysphagia (ER visit) | General disorders | Non-systematic Assessment |
|
| Ear and throat infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Eating disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Ecchymosis (post-op site) | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated bilirubin level | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Elevated TSH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Elevated WBC | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Endometriosis | General disorders | Non-systematic Assessment |
|
| Epigastric pain | General disorders | Non-systematic Assessment |
|
| Erosion on antrum (endoscopy) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophageal dilatation | General disorders | Non-systematic Assessment |
|
| Esophageal irritation | General disorders | Non-systematic Assessment |
|
| Esophageal pain | General disorders | Non-systematic Assessment |
|
| Esophagitis | General disorders | Non-systematic Assessment |
|
| Exacerbation of Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Excess skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Excess skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Facial skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Fainting | General disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flipped port | General disorders | Non-systematic Assessment |
|
| Frozen pelvis | Renal and urinary disorders | Non-systematic Assessment |
|
| Fungal infection | General disorders | Non-systematic Assessment |
|
| Gallstones | General disorders | Non-systematic Assessment |
|
| Gas pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric pouch dilatation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric pouch dilation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric pouch formation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| GE Reflux | General disorders | Non-systematic Assessment |
|
| GERD | General disorders | Non-systematic Assessment |
|
| Hair Thinning | General disorders | Non-systematic Assessment |
|
| Headaches | General disorders | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hiatal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hiatal hernia (Esophagram) | Gastrointestinal disorders | Non-systematic Assessment |
|
| HTN (Aggravated) | General disorders | Non-systematic Assessment |
|
| Hyperbilirubinemia | General disorders | Non-systematic Assessment |
|
| Hyperbilirubinemia (Aggravated) | General disorders | Non-systematic Assessment |
|
| Hypercholesterolemia | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Hypercholesterolemia (aggravated) | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Hypertriglyceridemia | General disorders | Non-systematic Assessment |
|
| Hypokalemia | General disorders | Non-systematic Assessment |
|
| Hypothyroidism | General disorders | Non-systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Iron deficiency | General disorders | Non-systematic Assessment |
|
| Kidney stones | Gastrointestinal disorders | Non-systematic Assessment |
|
| Knee injury (Left) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Leg cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Low Folate level | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Low Hb level | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Low iron level | General disorders | Non-systematic Assessment |
|
| Low iron level (Aggravated) | General disorders | Non-systematic Assessment |
|
| Low Vit. B12 level | General disorders | Non-systematic Assessment |
|
| Low Vit. D level | General disorders | Non-systematic Assessment |
|
| Low Vit. D level (Aggravated) | General disorders | Non-systematic Assessment |
|
| Low Vit. D level (Baseline:24) | General disorders | Non-systematic Assessment |
|
| Major depression | Cardiac disorders | Non-systematic Assessment |
|
| Meniscus dislocation (Left) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Meniscus tear | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Migraine | General disorders | Non-systematic Assessment |
|
| Monocleosis | Immune system disorders | Non-systematic Assessment |
|
| Mononucleosis | Immune system disorders | Non-systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | Non-systematic Assessment |
|
| Mumps | Infections and infestations | Non-systematic Assessment |
|
| Narcotic addition | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Neck pain | General disorders | Non-systematic Assessment |
|
| Numbness after exposing bright light | Immune system disorders | Non-systematic Assessment |
|
| Panic attack | Nervous system disorders | Non-systematic Assessment |
|
| Panic disorder | Nervous system disorders | Non-systematic Assessment |
|
| Port leak | General disorders | Non-systematic Assessment |
|
| Port protrusion | General disorders | Non-systematic Assessment |
|
| Port site pain | General disorders | Non-systematic Assessment |
|
| Post op site infection | General disorders | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Pregnancy with abortion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Psoriasis (Aggravated) | Immune system disorders | Non-systematic Assessment |
|
| Reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Seasonal allergies | Immune system disorders | Non-systematic Assessment |
|
| Self-inflicted forearm laceration | General disorders | Non-systematic Assessment |
|
| Shoulder pain | General disorders | Non-systematic Assessment |
|
| Sinus infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
| Strep throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Suicidal threats | Psychiatric disorders | Non-systematic Assessment |
|
| Testicular torsion | General disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Immune system disorders | Non-systematic Assessment |
|
| Tooth pain | Immune system disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Thrombocytopenia (small fat) | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Viral gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vit. D Deficiency | General disorders | Non-systematic Assessment |
|
| Wound dehiscence | General disorders | Non-systematic Assessment |
|
| Yeast infection | Infections and infestations | Non-systematic Assessment |
|
Not provided
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |