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Trial Title:
Visualization of the Papilla Through Use of the NuView Device in Patients With FAP
NCT ID:
NCT05657145
Condition:
Familial Adenomatous Polyposis
Conditions: Official terms:
Adenomatous Polyposis Coli
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Summary:
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:
- can the papilla be visualized using a forward-facing endoscope outfitted with the
NuView device. Participants will undergo standard of care esophagogastroduodenoscopy
with an additional endoscopic exam using NuView device, for which participant have
given prior consent.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Male or female, 18 to 70 years of age.
- Able to provide written informed consent.
- Have FAP
Exclusion Criteria:
- Females who are pregnant. As part of routine pre-operative care, all females of
childbearing potential will undergo either urine or blood pregnancy testing.
- Cancer positive subjects or any patients currently undergoing any treatment or
therapy to treat, cure, or mitigate cancer.
- Patients who do not meet inclusion criteria
- Patients who are unable or unwilling to provide informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37129
Country:
United States
Start date:
January 27, 2023
Completion date:
December 15, 2024
Lead sponsor:
Agency:
Vanderbilt University Medical Center
Agency class:
Other
Source:
Vanderbilt University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05657145
