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OpenTrials
Completed

NCT Number: NCT05657145

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

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visualization of papilla

    Time frame: 1 day

    Successful visualization of the papilla with a standard gastroscope equipped with the NuView platform.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: NuView

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2022
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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