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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05657145
Other study ID # NuView_220899
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 27, 2023
Est. completion date December 15, 2024

Study information

Verified date February 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 3
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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