NCT05990218

Brief Summary

Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

February 13, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

August 6, 2023

Last Update Submit

December 9, 2024

Conditions

Colon Polyp

Keywords

colon polypartificial intellegencecolonoscopy

Outcome Measures

Primary Outcomes (1)

  • polyp detection rate

    the number of polyp detected during endoscopy

    during endoscopy

Secondary Outcomes (1)

  • type of polyp

    during endoscopy

Study Arms (4)

control, experienced

ACTIVE COMPARATOR

Patients received colonoscopy with double insertion of right sided colon under white light by experienced endoscopist

Device: control

control, beginner

ACTIVE COMPARATOR

Patients received colonoscopy with double insertion of right sided colon under white light by beginner endoscopist

Device: control

AI, experience

EXPERIMENTAL

Patients received colonoscopy with double insertion of right sided colon under AI by experienced endoscopist

Device: Artificial intellegence. CADe syste,

AI, beginner

EXPERIMENTAL

Patients received colonoscopy with double insertion of right sided colon under AI by beginner endoscopist

Device: Artificial intellegence. CADe syste,

Interventions

Artificial intellegence. CADe syste,DEVICE

The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.

AI, beginnerAI, experience
controlDEVICE

The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.

control, beginnercontrol, experienced

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants age 40-80 years

You may not qualify if:

  • History of colonic surgery (except appendectomy)
  • Lower gastrointestinal bleeding
  • unstable vital sign during endoscopy of pregnancy
  • history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, Thailand

RECRUITING

Related Publications (1)

  • Kamba S, Tamai N, Saitoh I, Matsui H, Horiuchi H, Kobayashi M, Sakamoto T, Ego M, Fukuda A, Tonouchi A, Shimahara Y, Nishikawa M, Nishino H, Saito Y, Sumiyama K. Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial. J Gastroenterol. 2021 Aug;56(8):746-757. doi: 10.1007/s00535-021-01808-w. Epub 2021 Jul 3.

    PMID: 34218329BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients were masked from being randomized to operator and endoscopic method
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Patients randomized to 4 arms: control with experienced operator, control with beginner operator, AI with experienced operator, AI with beginner operator
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

February 13, 2023

Primary Completion

February 12, 2026

Study Completion

February 28, 2026

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)