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The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.
This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.
Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)
Secondary Objective To compare
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-Guided biopsy needle (ProCore) | Active Comparator | Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle.
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| EUS-TCB needle (Quick-Core) | Active Comparator | Comparison of core biopsy needles.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-TCB needle (QuickCore) standard of care | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Specimen Length | 36 months | |
| Number of Needle Passes | 36 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M. DeWitt, M.D. | Indiana University 550 N. University Hospital UH 4100 Indianapolis, IN 46202-5121 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202-5121 | United States |
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85 participants were enrolled in this study but only 78 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quick Core Needle | |
| FG001 | ProCore Needle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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78 participants competed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | QuickCore Needle | |
| BG001 | ProCore Needle | |
| BG002 | Total |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Overall Specimen Length | Posted | Mean | Standard Deviation | mm | 36 months |
|
|
3 years that patients were enrolled.
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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 | Quick Core Needle |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John DeWitt, MD | Indiana University School of Medicine | 317-944-1113 | jodewitt@iu.edu |
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| EUS-Guided biopsy needle (ProCore) | Device |
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Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
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| Primary | Diagnostic Accuracy. | One patient was lost to follow up. Final diagnosis was unconfirmed. | Posted | Number | Percentage of participants | 36 months |
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| Secondary | Number of Needle Passes | Posted | Mean | Standard Deviation | Needle passes | 36 months |
|
|
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| 0 |
| 37 |
| 3 |
| 37 |
| EG001 | ProCore Needle | 0 | 41 | 3 | 41 |
| Melena | Gastrointestinal disorders | Non-systematic Assessment |
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| Retroperitoneal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausa/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
|
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