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

NCT05657145 | Completed

• 1 other identifier: NuView_220899
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Familial Adenomatous Polyposis

Outcome Measures

Primary Outcomes (1)

• Visualization of papilla

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

  1 day

Study Arms (1)

Familiar Adenomatous Polyposis

All patient in this group will have the NuView device used to assist in the visualization of the papilla.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Male or female, 18 to 70 years of age.
• Able to provide written informed consent.
• Have FAP

You may not qualify if:

• 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 are unable or unwilling to provide informed consent

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37129, United States

Location

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Keith L Obstein, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 20, 2022
• Study Start: January 27, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)