NCT05657145

Visualization of the Papilla Through Use of the NuView Device in Patients With FAP

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Familial Adenomatous Polyposis

Timeline

• Start date: 2023-01-27
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2022-12-20
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States