A multicenter randomized controlled study to evaluate efficacy of a real-time endoscopic diagnosis support system using artificial intelligence technology for the detection of colorectal precancerous lesions and early colorectal cancer

Diagnostic yield Evaluation Studies of a real-time endoscopic Image diaGNosis support system using Artificial Intelligence technology - DESIGN AI-05 Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053438

Enrollment

1000

Registered

2024-10-28

Start date

2024-10-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal precancerous lesions and colorectal cancer (confirmed and suspected)

Interventions

Normal monitor (no AI group) Normal monitor + AI monitor (group with AI)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The physician in charge of the examination has a cumulative experience of 500 cases or more 2) Patients undergoing colonoscopy 3) Age: 20 years old or older and 90 years old or younger (age at the time of registration) 4) ECOG performance status score: 0-2 5) Purpose of examination: ?Examination after positive fecal occult blood results ?Surveillance after polypectomy ?Surveillance after colorectal cancer surgery ?Screening 6) Restrictions on concomitant drugs/concomitant therapy: ?Patients who can discontinue anticoagulant/antiplatelet agents according to the clinical practice guidelines for gastrointestinal endoscopy 7)Written informed consent has been obtained from the patient to participate in the study

Exclusion criteria

Exclusion criteria: 1) Restrictions on medical history and comorbidities: ?Patients who are currently undergoing chemotherapy or radiotherapy for colorectal cancer ?Patients with familial adenomatous polyposis ?Patients with comorbidities (such as chronic hematological disorders) that make lesion resection difficult ?Patients with active inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.)

Design outcomes

Primary

Measure	Time frame
PDR (Polyp Detection Rate)	—

Secondary

Measure	Time frame
1) ADR (Adenoma Detection Rate) 2) APPC (Adenomas Per Positive Colonoscopy: number of adenomas detected per positive test) 3) Total examination time 4) Endoscopy insertion time 5) Observation time 6) SSL (Sessile Serrated Lesion) detection rate in whole colon and right colon 7) FDR (Flat adenoma detection rate): Flat adenoma includes macroscopic type IIa, IIb, and IIc 8) DDR (Depressed lesion Detection Rate): Depressed lesion includes macroscopic type IIc alone	—

Measure

Time frame

1) ADR (Adenoma Detection Rate) 2) APPC (Adenomas Per Positive Colonoscopy: number of adenomas detected per positive test) 3) Total examination time 4) Endoscopy insertion time 5) Observation time 6) SSL (Sessile Serrated Lesion) detection rate in whole colon and right colon 7) FDR (Flat adenoma detection rate): Flat adenoma includes macroscopic type IIa, IIb, and IIc 8) DDR (Depressed lesion Detection Rate): Depressed lesion includes macroscopic type IIc alone

—

Countries

Japan

Contacts

Public ContactMasayoshi Yamada

National Cancer Center Hospital Division of Endoscopy

masyamad@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026