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The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2.
LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and < 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LapBand | Experimental | All subjects who receive the LAP-BAND System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAP-BAND System | Device | Reduction of food intake due to creation of smaller stomach pouch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation | The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Loss | Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2. | Baseline through 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle | Washington | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23637029 | Result | Michaelson R, Murphy DK, Gross TM, Whitcup SM; LAP-BAND Lower BMI Study Group. LAP-BAND for lower BMI: 2-year results from the multicenter pivotal study. Obesity (Silver Spring). 2013 Jun;21(6):1148-58. doi: 10.1002/oby.20477. |
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155 Subjects were enrolled per protocol (defined as signing the informed consent). After enrollment, 4 subjects withdrew consent prior to treatment, and 2 subjects were not implanted due to ineligibility discovered during screening. This resulted in 149 subjects starting the study and receiving treatment with the LAP-BAND System.
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| ID | Title | Description |
|---|---|---|
| FG000 | LapBand | All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | LapBand | Subjects implanted with the LapBand(R) Adjustable Gastric Band System |
| 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 | Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation | The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100. | Intent-to-treat (ITT) | Posted | Number | percentage of subjects | One year |
|
|
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 | Subjects implanted with the LapBand(R) Adjustable Gastric Band System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cavity abscess | Gastrointestinal disorders | MedDRA | Non-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 | Apollo Endosurgery | 949-468-9301 | laura.eaton@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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| Change in Comorbid Conditions Related to Obesity |
Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as "none" on a severity scale of none, mild, moderate, or severe) 12 months after implantation. |
| 12 months |
| Change in Quality of Life | Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported. | 12 months |
| Other loss to follow-up |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Percent Weight Loss | Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2. | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | percentage of weight loss | Baseline through 12 months |
|
|
|
| Secondary | Change in Comorbid Conditions Related to Obesity | Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as "none" on a severity scale of none, mild, moderate, or severe) 12 months after implantation. | Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27) | Posted | Number | percentage of subjects | 12 months |
|
|
|
| Secondary | Change in Quality of Life | Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported. | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Post-Hoc | Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation | The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2. | Intent-to-treat (ITT) | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
|
|
|
| Post-Hoc | Subject Percent Excess Weight Loss (5 Years) | The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)*100. | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | percentage of excess weight loss | 5 years |
|
|
|
| Post-Hoc | Change in Obesity Related Comorbid Conditions (5 Years) | Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL < 100 mg/dL, triglycerides < 150 mg/dL, and total cholesterol < 200 mg/dL. Hypertension resolution was defined as systolic blood pressure < 140 mm Hg. | Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49) | Posted | Number | percentage of subjects | 5 years |
|
|
|
| Post-Hoc | Change in Quality of Life (5 Years) | Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 5 years in IWQOL-Lite Total Score is reported. | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | 5 years |
|
|
|
| 18 |
| 149 |
| 145 |
| 149 |
| Band erosion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysphagia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastric outlet obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Esophageal spasms | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastric prolapse | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Umbilical hernia contained LAP-BAND tubing | General disorders | MedDRA | Non-systematic Assessment |
|
| Recurrent gastric stricture | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Band slip | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Hiatal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Biliary colic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Cholelithiasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Pouch dilation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Esophageal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Gastric dilation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Regurgitation of food | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Esophageal dilation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Implant site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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