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The goal of this observational study is to test the NuView device in participants with familial adenomatous polyposis (FAP). The main question it aims to answer is:
The clinical practice at Vanderbilt University Medical Center will first perform the routine upper endoscopic exam with a forward-viewing gastroscope to evaluate the patient's esophagus, stomach, and duodenum. After this has been completed, the forward-viewing endoscope will be removed from the patient and outfitted with the EndoTheia NuView. The endoscope with NuView will then be inserted transorally down the esophagus, traverse the stomach, and be passed into the duodenum for visualization of the papilla. After the papilla is visualized, the endoscope with NuView will be removed from the patient. As per standard of care, the conventional side-viewing endoscope will then be inserted transorally down the esophagus, traverse the stomach, and be passed into the duodenum for visualization of the papilla. The side-viewing endoscope will then be removed from the patient. The Investigators plan to enroll 3 FAP patients who are already scheduled to undergo their standard of care endoscopic exam. The primary endpoint of the study is successful visualization of the papilla with the NuView platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Familiar Adenomatous Polyposis | All patient in this group will have the NuView device used to assist in the visualization of the papilla. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visualization of papilla | Successful visualization of the papilla with a standard gastroscope equipped with the NuView platform. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Potential subjects will be identified from patients in the Vanderbilt University Medical Center Digestive Disease Center who are scheduled to undergo their endoscopic screening for FAP. FAP is a hereditary condition in which a person develops numerous precancerous polyps, called adenomas, within the small and large intestine. Currently, it is recommended that FAP patients undergo serial endoscopic exams to assess the colon for polyp formation every year and every 2-3 years to look for adenomas in the small intestine-specifically on the duodenal papilla.
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| Name | Affiliation | Role |
|---|---|---|
| Keith L Obstein, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37129 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2022 | Nov 23, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2022 | Nov 23, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011125 | Adenomatous Polyposis Coli |
| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |