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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05657145

Acronym

NuView

Enrollment

Registered

2022-12-20

Start date

2023-01-27

Completion date

2025-12-30

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Adenomatous Polyposis

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visualization of papilla	1 day	Successful visualization of the papilla with a standard gastroscope equipped with the NuView platform.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKeith L Obstein, MD

Vanderbilt University Medical Center

Outcome results