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MASTERPIECE study

A Multicenter Single-Arm Prospective Performance Evaluation Study to Assess the Performance of an AI Instrument to Support Qualitative Diagnosis of Colorectal Polyps - MASTERPIECE study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072220003
Enrollment
170
Registered
2022-04-20
Start date
2022-05-10
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

Patients who undergo colonoscopy Patients who undergo colonoscopy

Interventions

Using artificial intelligence (AI) for endoscopic diagnosis with colonoscopy
artificial intelligence (AI)

Sponsors

Uraoka Toshio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients between 20 and 85 years old at the time of registration who undergo colonoscopy 2.Patients who undergo colonoscopy (patients who meet any of the following conditions) -Positive fecal occult blood -Patients who need to undergo surveillance colonoscopy after polypectomy for colorectal polyp (including mucosal resection and submucosal dissection for early stage cancer) -Patients who have gastrointestinal symptoms such as abdominal pain, diarrhea or constipation -Patients who need to undergo screening colonoscopy for colorectal cancer -Patients who are recommended to undergo colonoscopy by their physician 3.Patients who can understand the content forms, those who can make a decision by themselves and those who can give written consent

Exclusion criteria

Exclusion criteria: 1.Patients with inflammatory bowel disease 2.Patients with familial adenomatous polyposis 3.Patients with a history of colorectal resection except appendicectomy 4.Patients with colorectal stenosis 5.Pregnant patients 6.Patients with abnormal blood coagulation function 7.Patients who cannot be managed with anticoagulant and/or antiplatelet agents according to the guidelines published by Japan Gastroenterological Endoscopy Society 8.Patients with severe organ failure 9.Patients who are not suitable for enrollment in the present study judged by their physician

Design outcomes

Primary

MeasureTime frame
Accuracy of endoscopic diagnosis with AI

Secondary

MeasureTime frame
1.Sensitivity and specificity of endoscopic diagnosis with AI 2.Accuracy, sensitivity and specificity of endoscopic diagnosis made by endoscopists 3.Differences of accuracy, sensitivity and specificity of endoscopic diagnosis between trainees and experts of colonoscopy 4.Differences of accuracy, sensitivity and specificity of endoscopic diagnosis by characteristics of lesions (size, morphology and location of lesions) between endoscopists and AI 5.Differences of endoscopists confidence level on endoscopic diagnosis between diagnosing with AI and without AI 6.Rates of adverse events (perforation or postoperative bleeding, etc.)

Contacts

Public ContactKeigo Sato

Gunma University Hospital

k.sato@gunma-u.ac.jp+81-27-220-8137

Outcome results

None listed

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