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Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spiral overtube | Other | Any subject that has been referred for spiral enteroscopy will be asked to participate in this study. The purpose is to gather data about the technical aspects of the procedure,diagnostic capability and treatment as well as long term follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| overtube use during enteroscopy | Device | use of overtube for the regular scheduled enteroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Persistent or Recurrent Bleeding | The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy. | up to 6 yrs after after the endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Draganov, MD | University of Florida, Division of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands at UF | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22771101 | Derived | Williamson JB, Judah JR, Gaidos JK, Collins DP, Wagh MS, Chauhan SS, Zoeb S, Buscaglia JM, Yan H, Hou W, Draganov PV. Prospective evaluation of the long-term outcomes after deep small-bowel spiral enteroscopy in patients with obscure GI bleeding. Gastrointest Endosc. 2012 Oct;76(4):771-8. doi: 10.1016/j.gie.2012.05.025. Epub 2012 Jul 7. | |
| 20632098 |
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The only significant event was that the subject was scheduled for an enteroscopy in our facility and a overtube was used at the time of endoscopy.
We started this study in June 2007 and ended this study in Oct 2012. We approached any patient who was scheduled in our endoscopy suite for an overtube enteroscopy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enteroscopy | Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enteroscopy | Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Patients With Persistent or Recurrent Bleeding | The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy. | Posted | Number | participants | up to 6 yrs after after the endoscopy |
|
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The adverse event data were collected for 6 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 | Enteroscopy | Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment | Two subjects experienced bradycardias during endoscopy and were hospitalized overnight for observation. |
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No limitations were found
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Draganov MD | University of FLorida | 352-273-9472 | peter.draganov@medicine.ufl.edu |
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| Judah JR, Collins D, Gaidos JK, Hou W, Forsmark CE, Draganov PV. Prospective evaluation of gastroenterologist-guided, nurse-administered standard sedation for spiral deep small bowel enteroscopy. Dig Dis Sci. 2010 Sep;55(9):2584-91. doi: 10.1007/s10620-010-1335-x. Epub 2010 Jul 15. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 8 |
| 193 |
| 0 |
| 193 |
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| Chest pain | Cardiac disorders | Systematic Assessment | One subject experience Chest pain after endoscopy and was hospitalized overnight for observation. |
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| Transient Ischemic Attack | Vascular disorders | Systematic Assessment | One subject experienced a transient ischemic attack after endoscopy and was hospitalized overnight for observation. |
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| Ventrical Tachycardia Arrest | Cardiac disorders | Systematic Assessment | One subject experienced a ventrical tachycardia arrest and was hospitalized. |
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| Partial Thickness Mucosal Tear | Gastrointestinal disorders | Systematic Assessment | Three subjects experienced a partial thickness mucosal tear as part of their endoscopy. |
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