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The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duet TRS | Experimental | Subjects receive Duet TRS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duet TRS | Device | Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room (OR) Time | OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port. | Day 0 |
| Length of Hospital Stay | Days spent in the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurora Pryor, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
Subjects were evaluated for pre-operative and intra-operative eligibility criteria prior to enrollment.
Between November 24, 2009 and March 29, 2010, a total of 29 patients were consented and screened for potential study participation at one institution (Duke University). Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duet TRS | Duet TRS is a staple line buttress |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
number of subjects consented
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| ID | Title | Description |
|---|---|---|
| BG000 | Duet TRS | Subjects receive Duet TRS Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS. |
| 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 | Incidence of Adverse Events. | Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis. | Posted | Number | adverse events | Day 30 |
|
|
1 month
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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 | Duet TRS | Duet TRS is a staple line buttress |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrojejunal Anatomosis Stricture | Gastrointestinal disorders | MedDRA | Non-systematic Assessment | Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noreen Fahey, Director, Clinical Program Management | Covidien | 203-821-4716 | noreen.fahey@covidien.com |
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| Day 2 (Approximately 1.5 days post randomization) |
| Incidence of Stapler 'Misfires' | The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth. | Day 0 |
| years |
|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Secondary | Operating Room (OR) Time | OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port. | Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis. | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
| Secondary | Length of Hospital Stay | Days spent in the hospital | Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis. | Posted | Mean | Standard Deviation | days | Day 2 (Approximately 1.5 days post randomization) |
|
|
|
| Secondary | Incidence of Stapler 'Misfires' | The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth. | Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis. | Posted | Number | participants | Day 0 |
|
|
|
| 2 |
| 27 |
| 0 |
| 27 |
|
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