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A prospective, international, multi-center study of clinical outcomes and estimated healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND AP® Adjustable Gastric Banding System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LapBand | Patients who have already consented to 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 | The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| %TBWL | Percent of total body weight change. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that have already made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Everett | Washington | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29265773 | Derived | Dixon JB, Eaton LL, Curry T, Lee PC. Health Outcomes and Explant Rates After Laparoscopic Adjustable Gastric Banding: A Phase 4, Multicenter Study over 5 Years. Obesity (Silver Spring). 2018 Jan;26(1):45-52. doi: 10.1002/oby.22050. | |
| 26154653 | Derived | Lao WL, Malone DC, Armstrong EP, Voellinger D, Somers S, Jin J, Dreyer N, Globe D. Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2 year analysis. Curr Med Res Opin. 2015 Aug;31(8):1451-60. doi: 10.1185/03007995.2015.1059802. Epub 2015 Jul 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LapBand | Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LapBand | Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | %TBWL | Percent of total body weight change. | Patients who attended 5 year visit. | Posted | Mean | Standard Deviation | % TBWL | 5 years |
|
|
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 | LapBand | Patients who have already consented to receive the LAP-BAND AP® Adjustable Gastric Banding System LAP-BAND AP® Adjustable Gastric Banding System: The LAP-BAND AP® is a device surgically implanted via a laparoscopic procedure. It is designed to induce weight loss in severely obese patients by limiting food consumption. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Apollo Endosurgery Inc | 512-279-5157 | jose.naveira@apolloendo.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Adelaide |
| South Australia |
| Australia |
| Jette | Belgium |
| Mississauga | Ontario | Canada |
| Naples | Italy |
| Birmingham | United Kingdom |
| 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 2 |
| 652 |
| 106 |
| 652 |
| 402 |
| 652 |
| General disorders and administration site conditions | General disorders | Systematic Assessment |
|
| Hepatobiliary disorder | Hepatobiliary disorders | Systematic Assessment |
|
| Infections | Infections and infestations | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
| congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
| Gastrointestinal disorders-unrelated to device or procedure | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders-unrelated to device or procedure | General disorders | Systematic Assessment |
|
| Hepatobiliary disorders-unrelated to device or procedure | Hepatobiliary disorders | Systematic Assessment |
|
| infections and infestations-unrelated to device or procedure | Infections and infestations | Systematic Assessment |
|
| Injury, poisoning and procedural complications-unrelated to device or procedure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Metabolism and nutrition disorders-unrelated to device or procedure | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal-unrelated to device or procedure | Metabolism and nutrition disorders | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified-unrelated to device or procedure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nervous system-unrelated to device or procedure | Nervous system disorders | Systematic Assessment |
|
| Pregnancy, puerperium and perinatal-unrelated to device or procedure | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Psychiatric disorders-unrelated to device or procedure | Psychiatric disorders | Systematic Assessment |
|
| Renal and urinary disorders-unrelated to device or procedure | Renal and urinary disorders | Systematic Assessment |
|
| Reproductive system and breast disorders-unrelated to device or procedure | Reproductive system and breast disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders-unrelated to device or procedure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders-unrelated to device or procedure | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical and medical procedures-unrelated to device or procedure | Surgical and medical procedures | Systematic Assessment |
|
| Vascular disorders-unrelated to device or procedure | Vascular disorders | Systematic Assessment |
|
| gastric polapse | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pouch dilatation | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |