Napoleon Device for Measuring Colonic Polyps

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Napoleon to measure the size of colonic polyps (small growths in the colon lining) during colonoscopies. The goal is to determine if Napoleon improves the accuracy of polyp size measurement compared to visual estimation. Accurate measurement could guide appropriate follow-up care based on polyp sizes. The trial seeks adults aged 45 and up who are undergoing a colonoscopy by a gastroenterology fellow and can provide consent. Participants should not have a history of difficult colonoscopies or be undergoing the procedure for certain known conditions. As an Early Phase 1 trial, this research aims to understand how the new device functions in people, offering participants a chance to contribute to pioneering advancements in colonoscopy technology.

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 prior data suggests that the Napoleon device is safe for measuring colonic polyps?

Research has shown that the Napoleon device helps doctors measure polyp size more accurately during a colonoscopy. This accuracy is crucial because it can influence the frequency of follow-up exams for patients.

Although limited safety data exists for the Napoleon device, this trial is in an early stage. The primary goal is to determine the device's safety for use in people. In early trials like this, researchers are just beginning to assess how well patients tolerate the device.

Overall, despite the lack of detailed safety data, the early stage of the trial ensures that safety is under close observation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Napoleon Device because it aims to improve the accuracy of measuring colonic polyps compared to the usual visual estimation method used during colonoscopies. Unlike visual estimation, which can be subjective and vary between practitioners, the Napoleon Device provides precise and consistent measurements, potentially leading to better diagnosis and treatment planning. This advancement could enhance patient outcomes by ensuring that polyps are accurately assessed and appropriately managed, reducing the risk of overlooking significant findings.

What evidence suggests that the Napoleon device is effective for measuring colonic polyps?

Research has shown that the Napoleon Endoscopic measuring device helps doctors measure colonic polyps more accurately. In this trial, participants will have their polyp sizes measured using either the Napoleon device or visual estimation. One study found that the Napoleon device improved the precision of polyp size measurement, leading to better decisions after a colonoscopy. Accurate measurement is especially important for polyps smaller than 10 mm, as it can influence the recommended follow-up care. The device is easy for doctors in training to use, making it a practical tool in medical settings. Overall, the Napoleon device enhances the measurement process and ensures more precise treatment plans. ^{2 3 4 5 6}

Who Is on the Research Team?

Renee Williams, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9886501/

Comparing size measurement of colorectal polyps using a ... Results A total of 360 measurements were performed. The relative accuracy of BF, ER, and VSE was 78.9 % (95 %CI = 76.2–81.5), 78.4 % (95 %CI = ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2590030721000453

How to Approach Small Polyps in Colon: Tips and Tricks This is especially helpful for polyps less than 10 mm in size. Most recently the Napoleon Endoscopic measuring device has been designed to assess polyp size ...

3. clinicaltrial.be clinicaltrial.be/en/details/44726?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Use of the Napoleon to Improve Polyp Measurement in ... This is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a Micro-Tech Endoscopic Polyp ...

4. researchgate.net researchgate.net/publication/366831196_Comparing_size_measurement_of_colorectal_polyps_using_a_novel_virtual_scale_endoscope_endoscopic_ruler_or_forceps_A_preclinical_randomized_trial

Comparing size measurement of colorectal polyps using a ... Secondary outcomes included misclassification of sizes at the 5-, 10-, and 20-mm thresholds. Results A total of 360 measurements were performed.

5. nyulangone.org nyulangone.org/news/endoscopic-measuring-tool-helps-assess-polyps-during-colonoscopy-inform-surveillance-intervals

Endoscopic Measuring Tool Helps Assess Polyps During ... Pochapin, the Micro-Tech Napoleon endoscopic gauge helped doctors to more accurately measure polyp size, better informing post-colonoscopy clinical management.

6. journals.lww.com journals.lww.com/ajg/fulltext/2023/10001/s425_use_of_the_napoleon_to_improve_polyp.781.aspx

S425 Use of the Napoleon to Improve Polyp Measurement ... Napoleon can offer a more accurate assessment of polyp size, which affects recommended surveillance interval time.