NCT03637712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2019

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

August 16, 2018

Last Update Submit

May 14, 2020

Conditions

Screening Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection Rate

    the proportion of colonoscopic examinations performed that detect one or more polyp

    1 Day

Study Arms (1)

Screening Colonoscopy

EXPERIMENTAL

Patients undergoing standard screening or surveillance colonoscopy will be included

Device: Computer Algorithm

Interventions

Computer AlgorithmDEVICE

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

Screening Colonoscopy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Seth Gross, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 20, 2018

Study Start

September 1, 2018

Primary Completion

July 7, 2019

Study Completion

July 7, 2019

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

US(1)