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Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stoma Adjustment at Surgery | Experimental | The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment. |
|
| Historic | No Intervention | Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoFLIP device (FDA Device Listing Number : D091203) | Device | The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm. |
| Measure | Description | Time Frame |
|---|---|---|
| %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) | 4-6 weeks post surgery | |
| %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) | 4-6 weeks post surgery | |
| % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) | 12m post surgery | |
| % Excess Weight Loss 12 Months After Surgery (Small Bands Only) | 12m post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Band Adjustments Required in the First Year After Surgery | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Snow, DO FACOS | AIGB | Principal Investigator |
| John O'Dea, PhD | Crospon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialty Surgery of Fort Worth | Hurst | Texas | 76054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Snow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12. |
| Label | URL |
|---|---|
| Wellcome Trust funding announcement | View source |
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N/A - Single arm non-randomized study
35 pts recruited between Oct 2009 and Jan 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Stoma Adjustment at Surgery | The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery |
| FG001 | Historic | Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4-6w |
| |||||||||||||
| 12m |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Historic | Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records |
| BG001 | Stoma Adjustment at Surgery | The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery |
| 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 | %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) | Posted | Mean | Standard Deviation | %EWL | 4-6 weeks post surgery |
|
|
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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 | Historic | Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John O'Dea PhD | Crospon | +353-91-519880 | jodea@crospon.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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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Band Adjustments Required in the First Year After Surgery | Posted | Mean | Standard Deviation | Number of Adjustments | 12 months |
|
|
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| Primary | %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) | Posted | Mean | Standard Deviation | %EWL | 4-6 weeks post surgery |
|
|
|
| Primary | % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) | Posted | Mean | Standard Deviation | %EWL | 12m post surgery |
|
|
|
| Primary | % Excess Weight Loss 12 Months After Surgery (Small Bands Only) | Posted | Mean | Standard Deviation | %EWL | 12m post surgery |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Stoma Adjustment at Surgery | The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery | 0 | 35 | 0 | 35 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |