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Napoleon Device for Measuring Colonic Polyps

Q: What is the maximum allowable cohort size for this clinical trial?

<p>Absolutely. Clinicaltrials.gov confirms that this clinical study is presently attempting to recruit 150 participants from 4 sites, the first of which was posted on June 14th 2021 and last updated on May 6th 2022.</p>

Q: Is registration for this trial currently open?

<p>Affirmative. According to the clinicaltrials.gov listing, this medical trial is still seeking patients for enrollment. It was first posted on June 14th 2021 and then modified most recently on May 6th 2022. Altogether, 150 individuals need to be recruited from 4 distinct sites.</p>

Phase < 1

Recruiting

Led By Renee Williams, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients: Adult age 45 and above

Patients: Undergoing a colonoscopy performed by a gastroenterology fellow

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is assessing the accuracy of a new device for measuring colonic polyps.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on measurement methods rather than medication or invasive procedures, there are no direct side effects from the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 45 years old or older.

Select...

I am scheduled for a colonoscopy by a gastroenterology fellow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in accuracy of polyp measurement among fellow years

Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon

Difference in polyp measurement between histology and using Napoleon

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Colonoscopy Patients + their Gastroenterology FellowsExperimental Treatment2 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,680 Total Patients Enrolled

1 Trials studying Colorectal Adenomas

138 Patients Enrolled for Colorectal Adenomas

Renee Williams, MDPrincipal InvestigatorNYU Langone Health

Media Library

Colonoscopy Patients + their Gastroenterology Fellows Clinical Trial Eligibility Overview. Trial Name: NCT04858477 — Phase < 1

Colorectal Adenomas Research Study Groups: Colonoscopy Patients + their Gastroenterology Fellows

Colorectal Adenomas Clinical Trial 2023: Colonoscopy Patients + their Gastroenterology Fellows Highlights & Side Effects. Trial Name: NCT04858477 — Phase < 1

Colonoscopy Patients + their Gastroenterology Fellows 2023 Treatment Timeline for Medical Study. Trial Name: NCT04858477 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum allowable cohort size for this clinical trial?

"Absolutely. Clinicaltrials.gov confirms that this clinical study is presently attempting to recruit 150 participants from 4 sites, the first of which was posted on June 14th 2021 and last updated on May 6th 2022."

Answered by AI

Is registration for this trial currently open?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial is still seeking patients for enrollment. It was first posted on June 14th 2021 and then modified most recently on May 6th 2022. Altogether, 150 individuals need to be recruited from 4 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

2021. "Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04858477.

All > Gastroenterology