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The purpose of this protocol is to determine how band fill volumes that are based on intraband pressure readings can influence the comfortability of the band and to compare weight loss with this methodology to weight loss with the conventional approach recommended in existing product labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Adjustment Group | Active Comparator | Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
|
| Intraband Pressure Arm | Active Comparator | Subjects whose band adjustments will be guided by intraband pressure readings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraband pressure recording system | Device | Intraband pressure will be measured by a pressure recording system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Excess Weight Change at Day 180 | Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range. | Screening to Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Static Intraband Pressure at Day 180 | Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition) | Day 180 |
| Rate of Weight Loss kg/wk at Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide Bariatric Center | Bedford Park | South Australia | 5042 | Australia | ||
| OB Klinika, a.s. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Adjustment Group | Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
| FG001 | Intraband Pressure Arm | Subjects whose band adjustments will be guided by intraband pressure readings. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Adjustment Group | Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
| BG001 | Intraband Pressure Arm | Subjects whose band adjustments will be guided by intraband pressure readings. |
| 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 Excess Weight Change at Day 180 | Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range. | Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data. | Posted | Mean | Standard Deviation | percentage of excess weight at screening | Screening to Day 180 |
|
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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 | Conventional Adjustment Group | Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers Principal Biostatistician | Ethicon Endo-Surgery Inc. | 513-337-1172 | mschwier@its.jnj.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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| Conventional Adjustment | Other | Band adjustments will be made via conventional standard of care (e.g., volume, hunger). |
|
Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7). |
| Screening to Day 180 |
| Prague |
| Czechia |
| Repeated needle dislodgment |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Intraband Pressure Arm | Pressure adjustments based on protocol instructions regarding intraband pressure measurements |
|
|
|
| Secondary | Mean Static Intraband Pressure at Day 180 | Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition) | Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis. | Posted | Mean | Standard Deviation | mmHg | Day 180 |
|
|
|
|
| Secondary | Rate of Weight Loss kg/wk at Day 180 | Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7). | Per Protocol population | Posted | Mean | Standard Deviation | kg/week | Screening to Day 180 |
|
|
|
|
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | Intraband Pressure Arm | Subjects whose band adjustments will be guided by intraband pressure readings. | 1 | 26 | 11 | 26 |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | 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 |