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| ID | Type | Description | Link |
|---|---|---|---|
| 10686 | Other Identifier | NYULMC IRB | |
| G030190 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA
STUDY OBJECTIVES
STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation
DESIGN: Prospective single center study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAGB for low BMI patients | Experimental | the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAP-BAND® Adjustable Gastric Band (LAGB®) | Device | Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery | Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of LDL from baseline at 5 years | 5 years |
| Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Ren-Fielding, M.D. | NYUSOM | Principal Investigator |
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| Label | URL |
|---|---|
| NYU Program for Surgical Weight Loss | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lap-Band | Low BMI patients who will go through Lap-band surgery. LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LAP-BAND® Adjustable Gastric Band (LAGB®) Operations | A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery | Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight. | All participants who underwent LAGB are included in the analysis population. | Posted | Mean | Standard Deviation | percentage of excess weight loss | 5 years |
|
|
Entire 5 years study period
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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® Adjustable Gastric Band (LAGB®) Operations | A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Band revision/replacement | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Port revision/replacement | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heekoung Youn | NYULMC | 2122632174 | younh01@nyumc.org |
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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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Change in level of Triglycerides from baseline at 5 years
| 5 years |
| Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of HbA1c from baseline at 5 years | 5 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
|
| Secondary | Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of LDL from baseline at 5 years | All participants who underwent LAGB are included in the analysis population. | Posted | Mean | Standard Deviation | mg/dl | 5 years |
|
|
|
| Secondary | Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of Triglycerides from baseline at 5 years | All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population. | Posted | Mean | Standard Deviation | mg/dl | 5 years |
|
|
|
| Secondary | Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of HbA1c from baseline at 5 years | All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population. | Posted | Mean | Standard Deviation | percentage of HbA1c | 5 years |
|
|
|
| 14 |
| 50 |
| 4 |
| 50 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |