Effect of Two Colonoscopy AI Systems for Colon Polyp Detection

NCT05089071 | Completed

• 1 other identifier: SNUH IRB 2107-235-1240
• Study Type: interventional
• Target: 3,046
• Locations: 1 country
• Sites: 1

Brief Summary

Computer-aided detection (CADe) systems have been actively researched for polyp detection in colonoscopy. The investigators aim to identify the effect of two CADe systems according to the system performance on false positive rate

Conditions

Adenoma; Colonoscopy; Sessile Serrated Adenoma

Keywords

endoscopist; adenoma detection rate; colonoscopy; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Adenoma detection rate

  proportion of colonoscopies with at least one adenoma detected overall and as detected by the physician.

  12 months

• Sessile serrated lesion detection rate

  proportion of colonoscopies with at least one sessile serrated lesion detected overall and as detected by the physician.

  12 months

Secondary Outcomes (1)

• polyp detection rate

  12 months

Study Arms (2)

CADe group

EXPERIMENTAL

Endoscopists perform colonoscopy with CADe system

Device: Assist by artificial intelligence system for colon polyp detection

Control

NO INTERVENTION

Endoscopists perform colonoscopy without CADe system

Interventions

Assist by artificial intelligence system for colon polyp detection DEVICE

Assist by artificial intelligence system for colon polyp detection

CADe group

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient for screening or surveillance colonoscopy patients agreed with participating in the study

You may not qualify if:

• patients who do not agree with participating in the study patients with a history of colon resection patients with a history of inflammatory bowel resection patients with poor bowel preparation

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University: collaborator

Study Sites (1)

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.

  PMID: 32598963 BACKGROUND

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jung Ho Bae, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary outcome was the comparison of ADR between the control and AI groups according to the intervention system (SCAI vs ENAD system).

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: November 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 27, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)