Napoleon Device for Measuring Colonic Polyps

Recruiting at 3 trial locations

Overseen By Matthew O'Mara, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: NYU Langone Health

Disqualifiers: Difficult colonoscopies, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a Micro-Tech Endoscopic Polyp Measurement Device named Napoleon. The study will evaluate the feasibility of Napoleon as a polyp measurement device. Investigators will collect data on inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from May 2021 - May 2022 for 150 patients. Investigators will include all colonoscopies with polyps done in adults age 45 and above. For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. Investigators will calculate the difference in polyp measurement between visual assessment and using Napoleon for each fellow year and compare differences among fellow years. Investigators will evaluate for changes in fellows' accuracy of polyp measurement with subsequent uses of Napoleon. Investigators will determine the proportion of cases with a change in the recommended surveillance interval based on polyp size. A survey will be given to all fellows to assess the level of ease with using Napoleon.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Napoleon Device for measuring colonic polyps?

Research shows that accurate measurement of polyp size is crucial for assessing cancer risk, and various methods like CT colonography and ruler snares have been studied to improve precision. These studies highlight the importance of accurate size estimation, which the Napoleon Device aims to achieve, suggesting its potential effectiveness in providing reliable measurements. ^{1 2 3 4 5}

Is the Napoleon Device for Measuring Colonic Polyps safe for humans?

The research articles provided do not contain specific safety data for the Napoleon Device or similar methods for measuring colonic polyps, focusing instead on the accuracy and reliability of different measurement techniques. ^{1 3 6 7 8}

How does the Napoleon Device for Measuring Colonic Polyps differ from other treatments?

The Napoleon Device is unique because it provides a real-time, in situ measurement of colonic polyps, potentially offering more accurate and reliable size assessments compared to traditional methods like visual estimation or forceps measurement, which can be prone to errors. ^{1 6 7 9 10}

Research Team

Renee Williams, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults aged 45 or older undergoing a colonoscopy performed by gastroenterology fellows at select NYU locations. Participants must be able to give informed consent and not have any medical training in performing colonoscopies. Those with non-adenomatous polyps, incomplete polyp removals, or inflammatory bowel conditions are excluded.

Inclusion Criteria

Fellows: Willingness and ability to provide informed consent

I am 45 years old or older.

I am scheduled for a colonoscopy by a gastroenterology fellow.

Exclusion Criteria

I have polyps whose size is not clearly determined.

Patients: History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)

Patients: Colonoscopy without polyps

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Data collected on inpatient and outpatient colonoscopies performed by fellows using the Napoleon device

12 months

Multiple visits for colonoscopy procedures

Analysis

Analysis of polyp measurement accuracy and changes in recommended surveillance intervals

2 months

Follow-up

Participants are monitored for any changes in surveillance intervals based on polyp size

4 weeks

Treatment Details

Interventions

• Napoleon measurement of polyp size
• Visual estimation of polyp size

Trial Overview The study tests the accuracy of measuring colonic polyps using a device called Napoleon versus visual estimation by gastroenterology fellows during colonoscopies. The difference in measurements and changes in surveillance recommendations based on these measurements will be analyzed.

Participant Groups

Group I: Colonoscopy Patients + their Gastroenterology Fellows Experimental Treatment 2 Interventions

Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Is forceps more useful than visualization for measurement of colon polyp size? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The difference in colon polyp size before and after removal. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Polyp size measurement at CT colonography: what do we know and what do we need to know? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Use of a novel polyp "ruler snare" improves estimation of colon polyp size. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

CT colonography: automated measurement of colonic polyps compared with manual techniques--human in vitro study. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Reliability of in situ measurements of colorectal polyps. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Variable interpretation of polyp size by using open forceps by experienced colonoscopists. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Comparing size measurement of colorectal polyps using a novel virtual scale endoscope, endoscopic ruler or forceps: A preclinical randomized trial. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

A real-time deep learning-based system for colorectal polyp size estimation by white-light endoscopy: development and multicenter prospective validation. [2023]

10. Australia pubmed.ncbi.nlm.nih.gov

Comparing size measurements of simulated colorectal polyp size and morphology groups when using a virtual scale endoscope or visual size estimation: Blinded randomized controlled trial. [2023]