Familial Adenomatous PolyposisNuViewNCT05657145
Visualization of the Papilla Through Use of the NuView Device in Patients With FAP
An observational study of Familial Adenomatous Polyposis, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Familial Adenomatous Polyposis
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or female, 18 to 70 years of age.
- Able to provide written informed consent.
- Have FAP
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37129
About this study
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.
Read the 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
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Familiar Adenomatous Polyposis | All patient in this group will have the NuView device used to assist in the visualization of the papilla. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of papilla
Successful visualization of the papilla with a standard gastroscope equipped with the NuView platform.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start27 Jan 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Obstein, Vanderbilt University Medical Center
- Investigators
- Keith L Obstein, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657145
- Sponsor's protocol ID
- NuView_220899
- Acronym
- NuView
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of the Papilla Through Use of the NuView Device in Patients With FAP
- ClinicalTrials.gov ID
- NCT05657145
- Acronym / sponsor ID
- NuView / NuView_220899
- Conditions
- Familial Adenomatous Polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Familiar Adenomatous Polyposis | – | –All patient in this group will have the NuView device used to assist in the visualization of the papilla. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Male or female, 18 to 70 years of age.
- Able to provide written informed consent.
- Have FAP
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visualization of papilla
Time frame: 1 day
Successful visualization of the papilla with a standard gastroscope equipped with the NuView platform.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith L Obstein, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Adenomatous Polyposis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of papilla (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.