Deep-Learning for Automatic Polyp Detection During Colonoscopy

NCT ID: NCT03637712

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-07-07

Brief Summary

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The primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.

Detailed Description

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Conditions

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Screening Colonoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Screening Colonoscopy

Patients undergoing standard screening or surveillance colonoscopy will be included

Group Type EXPERIMENTAL

Computer Algorithm

Intervention Type DEVICE

This device is a computer algorithm that runs in the background during routine screening or surveillance colonoscopy that is designed to aid in the detection of polyps

Interventions

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Computer Algorithm

This device is a computer algorithm that runs in the background during routine screening or surveillance colonoscopy that is designed to aid in the detection of polyps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients presenting for routine colonoscopy for screening and/or surveillance purposes.
* Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria

* People with diminished cognitive capacity.
* The subject is pregnant or planning a pregnancy during the study period.
* Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed)
* Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
* Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
* Patients with inflammatory bowel disease
* Patients with any polypoid/ulcerated lesion \> 20mm concerning for invasive cancer on endoscopy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seth Gross, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18-00746

Identifier Type: -

Identifier Source: org_study_id

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